First Quality Jobs in Usa

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Director of Quality Initiatives and Improvement (DQI) leads all hospital-based work to eliminate preventable harm to patients, family members, and staff and to attain unsurpassed clinical and patient-reported outcomes for assigned hospital. The DQI builds organization-wide participation in improvement through transparency, collaboration and mutual learning. Reporting to the Regional Chief Quality Officer collaborates with leaders to achieve the HMH quality goals and eliminate preventable harm. The DQI facilitates the redesign of patient care processes; leads root cause analyses process, analyzes data to inform and guide improvement efforts, and develops organizational capacity for improvement through teaching and mentorship. While directing the assessment, planning, implementation, monitoring and evaluation of best practices, the DQI ensures that cost effective, quality care is administered to all patients in accordance with the hospital PI plan, while complying with the standards of all regulatory and accrediting agencies. Provides leadership in the implementation and integration of the Department of Patient Care Performance Improvement Plan in addition to ensuring JCAHO & regulatory compliance. Oversees various activities of the Patient Safety and Quality Department while aligning with the Medical Center and HMH Performance Improvement Plan in assuring compliance with all Patient Safety Indicators, Quality Care Transition Teams & Nursing Quality. Advances the integration of the science of patient safety and continuous learning throughout the organization.

A day in the life of a Director of Quality Initiatives and Improvement (DQI) at Hackensack Meridian Health includes:

• Provides leadership to all safety and quality improvement activities at a hospital including committee meetings, medical staff peer review, root cause and apparent cause analyses, event management, morning safety report, follow up of ONELink event reports, and specific improvement cycles.
• Provides leadership to local HRO transformation. Engages all levels of leadership, caregivers and staff in advancing patient safety through HRO training, morning safety huddles, and joint event management with the departments of Human Experience and Risk Management
• Develops and oversees organizational quality initiatives and the monitoring of quality priorities.
• Presents quality data results with analysis and recommendation to a variety of organizational committees and councils including Department of Patient Care to enhance achievement of HMH quality goals.
• Oversees all quality improvement staff and their work in quality councils, teams and committees. Ensures that their team members achieve certification by the National Patient Safety Foundation as a Certified Professional in Patient Safety (CPPS), attend conferences, and receive continuing education including presentation skills, project management, process mapping, and lean principles. Cultivates and promotes continuous learning inside and outside of the network.
• Ensures compliance with all federal and state regulatory and licensing requirements, including aspects of Joint Commission readiness.
• Directs root cause and apparent cause and common cause evaluation of events and follow up activities. Identifies events, near misses and opportunities for quality and system improvement through the use of event reports, morning safety huddles, and trends identified through data analysis. Presents risk reduction strategies and follow up at Patient Safety Council to facilitate shared learning and scalability where possible. Identifies appropriate metrics to track meaningful change.
• Guides continuous learning and transparency related to patient safety and quality initiatives- Incorporates continuous learning including evidence based best practices, scalable system improvements, safety stories with lessons learned and needs identified through claims, suits and events. Through analysis of data, distinguish isolated events from trends and deploy resources to address those impacting patient experience, outcomes and ROI. Engage all levels of caregivers and staff in advancing patient safety through HRO training, quality initiatives addressing small wins and when designing system improvement. Utilize a variety of modes to increase the reach including webinar, video conferencing and interactive presentations.
• Guides hospital work in achieving HMH annual and strategic quality goals.
• Participates as a non-voting member in the Hospital Peer Review Committee, where applicable. Leads initial case screening prior to submission to the committee.
• Ensures use of appropriate methodologies and relevant tools to achieve rapid cycle improvement (i.e. PDSA, FMEA, reliability science, bundle science, process flows).
• Collaborates with the Patient Safety and Quality Department as well as with the VP, Chief Quality/Safety to ensure that organizational wide safety and quality initiatives are implemented effectively and risk reduction strategies implemented wherever appropriate.
• Ensures effective analysis of performance data with comparison over time and comparisons to internal and external benchmarks to identify improvement opportunities.
• Oversees and facilitates regularly scheduled updates and educational sessions for physician and nursing leaders, managers, and team members throughout the organization so that they are able to use the monthly quality scorecard information and participate in achieving the HMH quality goals.
• Ensures trend analysis is completed and appropriate response to unfavorable trends are developed and deployed.
• Develops and implements action plans based on analysis of data results.
• Supervises the education of staff in regards to relevant performance improvement theories and tools to staff & managers.
• Communicates and educates on Joint Commission and Regulatory standards, assists with Joint Commission readiness.
• Ensure plans and designs are consistent with internal and external expectations for accreditation, regulatory compliance and public reporting.
• Aligns performance improvement to the Magnet philosophy.
• Responsible for interviewing and hiring of patient safety and quality staff and managing performance evaluations.
• Assuring all staff act in accordance with the Medical Center Code of Conduct.
• Member of the Patient Safety Committee, Performance Improvement Coordinating Committee, Nurse Executive Council, Nursing Operational Committee
• In concert with the HMH VP Patient Safety and High Reliability coordinates and oversees the completion of the National AHRQ Survey on the culture of safety and the annual National Leap Frog Survey for the Medical Center.
• Maintains professional growth and development through seminars, workshops and professional facilitations to maintain and extend expertise of self and team.

Education, Knowledge, Skills and Abilities Required:

• Master's Degree in Nursing, Health Care Administration, Public Health, other advanced health-related degree, or equivalent experience
• 7-10 years of clinical experience in an acute care hospital
• Experience with NDNQI & Magnet Accreditation
• 3-5 years of experience in patient safety and quality
• Proficient in the RCA-2 Process
• Strong communication and presentation skills.
• Experience in the use of computer application and software.
• Excellent written and oral communication skills.

Education, Knowledge, Skills and Abilities Preferred:

• Performance Improvement expertise
• HRO experience
• Mastery of performance improvement methodologies
• Highly collaborative leader
• Attainment of CPPS (certified professional in patient safety) within one year of hire

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!      

Our team members are the heart of what makes us better.

At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community.

Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of positive change.

The Manager of Patient Safety and Quality acts in conjunction with the Director of Patient Safety & Quality to provide leadership for quality & safety improvement initiatives. Collaborates with Hackensack Meridian Health (HMH) initiative-focused groups, clinical transformation services and quality councils to achieve transformational and sustainable outcome improvements using project/program management, process and system mapping, reliability science data driven strategies, evidence based best practices and quality improvement strategies. Provides ongoing support, instruction, and leadership to meet and exceed all accreditation standards, and to ensure ongoing readiness for accreditation throughout all accredited programs. Works with the Director Patient Safety and Quality to respond to and coordinate investigation by the Joint Commission, Department of Health (DOH) and other external regulatory agencies.

A day in the life of a Manager of Patient Safety and Quality at Hackensack Meridian Health includes:

• Orient and mentor new Department of Patient Safety and Quality team members. Provides feedback to Director of Patient Safety and Quality on team member performance evaluations
• Provide expert knowledge, leadership and mentoring in patient safety & quality initiatives utilizing safety and high reliability science.
• Monitor standards of practice to ensure compliance with codes of internal and external regulatory and accrediting agencies including: a. The Joint Commission b. NJ State and Federal Codes (i.e.: DOH, OSHA) c. Professional review organizations
• Chair organizational level committees/councils (i.e. Regulatory Steering Committee, Performance Improvement Committee).
• Facilitates/coordinates regulatory activities throughout all accredited programs.Collaborates with staff, physicians, and administration to ensure successful regulatory surveys.
• Facilitate patient safety and environment of care rounds with interprofessional collaboration with utilization of the Joint Commission AMP monitoring tool.
• Lead onsite regulatory surveys to respond to and coordinate investigation by the Joint Commission, DOH and other external regulatory agencies.
• Develops and implements hospital wide training to maintain compliance with Joint Commission and other regulatory standards.
• Facilitate and lead highly functioning teams organized around quality & safety initiatives.
• Identify improvement priorities specific to each HMH initiative-focused improvement work, clinical transformation service, or quality council based on evidence based practice, taking into consideration regulatory requirements and accrediting agencies such as CMS, Pay for Performance, The State of New Jersey Department of Health, and The Joint Commission.
• Bring safety and quality events, concerns and needs to the local morning safety huddle.
• Encourage event reporting and transparency related to events, concerns, needs, processes to identify precursor and safety events.
• Identify & implement data driven strategies to ensure team's success.
• Utilize the Quality dashboards to drive improvements by the HMH initiative-focused improvement work, clinical transformation service, or quality council.
• Strategize with personnel at all levels to develop and coordinate patient safety programs.
• Create and maintain timely and thorough progress reports that include key driver diagrams, run charts, Agile methods and PDSA testing documentation.
• Engage all levels of caregivers and staff in advancing patient safety through HRO training, quality initiatives addressing small wins and when designing system improvement.
• Develop metrics and report key quality & safety metrics to accurately demonstrate improvement in safety & quality across the medical center and network.
• Provide timely, actionable feedback and reports to clinical, administrative and support staff on all safety & quality initiatives.
• Ensure appropriate referral and follow up for events including escalation for regulatory reporting. Increase transparency, reinforce high reliability and advance the safety culture by participating in and facilitating safety huddles, patient safety activities, just culture reinforcement and shared learning. Facilitate the NPSF RCA-2 process as needed.
• Effective trend analysis of performance data with comparison over time to internal and external benchmarks to identify improvement opportunities, and progress.
• Attend root cause analysis meetings as specific to HMH initiative-focused group, clinical transformation service, or quality council focus area.
• Direct patient and team member safety by identification of actual or potential safety issues. Advance & enhance professional growth and development through seminars, workshops and professional networking opportunities to maintain and extend expertise.
• Other duties and/or projects as assigned
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Bachelor's degree in Nursing, Healthcare or health science field or other relevant area of study.
• Minimum of 5 or more years of experience in healthcare quality, patient safety, and regulatory.
• Performance Improvement experience.
• Understanding of the Joint Commission and regulatory standards.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• Master's degree in nursing, health care or health science.

Licenses and Certifications Required:

• Certified Professional in Patient Safety.

Licenses and Certifications Preferred:

• Certified Professional in Healthcare Quality.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!

Job Summary

Under the direction of the Quality Assurance Lab Supervisor, the Quality Technician Supervisor is responsible for overseeing day-to-day quality control activities and leading the technician team to ensure that all quality processes run smoothly. This position handles escalated quality issues, coordinates team schedules, supports training and development, ensures proper execution of quality processes, oversees team performance, and maintains compliance with established quality standards. The Lead also provides backup coverage for technical and administrative quality functions and plays a key role in fostering a culture of continuous improvement. This will be achieved while maintaining HellermannTyton's Quality and EHS certifications by supporting all corporate policies, procedures, work instructions and required documentation.

Essential Functions

• 
  
  
• Effectively manage outgoing and incoming shift transitions to understand any quality event escalations and maintain seamless Quality support across all shifts.
  
  
• Lead shift meetings, communicate quality event escalations, hold tickets, and provide common quality focus across all shifts.
  
  
• Set team priorities and assignments to align with priorities, production needs, and quality goals.
  
  
• Work with the production team to develop a bench of qualified candidates to address daily staff shortages and maintain the designated staffing levels.
  
  
• Monitor and approve escalation activities associated with Back Tracking, Red Stamp, and Hold Ticket processes to confirm the proper execution of the associated processes.
  
  
• Support escalated quality concerns and coordinate with production and engineering for resolution.
  
  
• Develop and manage employee schedules to ensure appropriate quality coverage to support production, including any necessary overtime.
  
  
• Train new quality team members, provide necessary records, and support their ongoing development.
  
  
• Continually monitor team performance, conduct process audits, reinforce good performance, identify opportunities for improvement, and support any necessary disciplinary actions.
  
  
• Investigate escalated accountability concerns, determine the cause of the escalation, and work with team to provide actions / follow-up to resolve the issue.
  
  
• Handle any employee relations concerns prior to the need for escalation.
  
  

Other Functions

• 
  
  
• Perform and/or supervise Hold Ticket, Backtracking, and Deviations processes
  
  
• Support the "Red Bin" meeting, disposition decisions, and follow-up as needed
  
  
• Perform "Red Stamp" reviews to confirm decision making and proper execution
  
  
• Support the quality element of the daily huddle meeting as needed
  
  
• Complete material certifications when needed
  
  

Success in this role will require

• 
  
  
• Proficient in MES, SQC PAC, and JDE systems.
  
  
• Strong computer skills, including Microsoft Word and Excel.
  
  
• Ability to read and interpret engineering drawings and blueprints.
  
  
• Excellent communication and interpersonal skills for cross-functional coordination.
  
  
• Highly organized, with strong recordkeeping and prioritization skills.
  
  
• Strong math skills and high attention to detail.
  
  
• Able to operate lab equipment and interpret testing results.
  
  
• Demonstrated leadership ability with mentoring experience preferred.
  
  

What You'll Bring

• 
  
  
• Qualifications (skills, knowledge, experience)
  
  
• High school diploma or equivalency, required.
  
  
• 4+ years of experience in a quality assurance role in manufacturing or related industry.
  
  
• Leadership or team coordination experience strongly preferred.
  
  
• Must be able to lift, push, and pull up to 50 lbs.
  
  
• Good vision and color identification required for inspections.
  
  
• Ability to work non-standard hours and respond to shift demands.
  
  
• Must be able to stand for 6-8 hours per shift.
  
  

Rev. 1.9.2026

COMP - 0003176

At Jabil, we make the world’s best brands better by designing, manufacturing, and delivering end-to-end solutions on a scale. Our Salisbury, NC site supports high-growth cloud infrastructure customers—from server and rack integration to data-center subsystems—where quality, speed, and traceability are non-negotiable.

How will you make an impact?

• As the Lead Quality Systems Engineer, you will serve as a guardian of Quality, shaping a Quality Management System that thrives on speed, security, and scalability. 

• This position requires proven experience with developing and implementing QMS in a new start up site. 

• The position also requires the skills to lead cross-functional teams to ensure that our products and processes align with ISO 9001:2015 expectations while still honoring the fast-moving rhythm to meet customer expectations. 

• Quality Systems requires a unique balance of technical precision and practical, streamlined solutions. As a unifying partner across teams, the Quality Systems Engineer provides positive leadership, challenges complacency, and drives continuous improvement—while ensuring processes remain efficient and free of unnecessary administrative burden.

What will you do ?

Quality Management System Leadership

• Establish a strong QMS foundation aligned with Jabil Global QMS and ISO 9001:2015 Standards. 

• Own the Quality Policy and measurable quality objectives throughout the site; monitor performance and drive corrective actions where needed. 

• Lead Management Review processes — ensuring data-driven decision-making and compliance visibility. 

Auditing & Compliance

• Plan and execute internal audits across engineering and operations (with focus on IC, Planning, and other core Manufacturing Processes), product management, customer support. 

• Serve as primary liaison with external auditors, certification bodies, and regulatory partners. 

• Track and ensure closure of nonconformities, corrective actions, and risk mitigations. A strong grip on basics such as FMEA and Control Plan is a plus point. 

• Champion structured problem-solving using 8D, RCA, FMEA, DMAIC or equivalent frameworks. 

Document & Process Ownership

• Own lifecycle management for QMS documentation — including processes, SOPs, Work Instructions, and Quality Records. 

• Partner with system owners to ensure traceability and version control across Jabil document control tools. 

Customer & Stakeholder Focus

• Integrate Voice of Customer (VoC) into QMS improvements and product roadmaps. 

• Lead quality representation in major incident reviews and customer-impacting events. 

• Track quality KPIs and present insights clearly into executive leadership. 

Training & Culture Building 

• Develop and deliver ISO 9001:2015 and QMS awareness training for all functions starting at New Employee Orientation. 

• Advocate for an initiative-taking quality culture — where quality is everyone’s job, not a bureaucratic checkpoint. 

Education:

• Bachelor’s degree in engineering or quality discipline (master’s preferred) 

Experience

• 5–8 years in Quality Engineering or Quality Systems roles; at least 2-3 years in leading Quality Management Systems

• Strong expertise in ISO 9001:2015 implementation and certification maintenance 

• Proven experience with internal and supplier audits 

• Data-driven mindset — Excel/Sheets mastery is preferred; bonus if familiar with BI tools (Power BI, Tableau) 

• Certifications (preferred): CQE, CQA, Lead Auditor, Six Sigma Green/Black Belt Etc. 

What Can Jabil Offer You?

Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options

• 401K Match

• Employee Stock Purchase Plan

• Paid Time Off

• Tuition Reimbursement

• Life, AD&D, and Disability Insurance

• Commuter Benefits

• Employee Assistance Program

• Pet Insurance

• Adoption Assistance

• Annual Merit Increases

• Community Volunteer Opportunities

At Jabil, we make the world’s best brands better by designing, manufacturing, and delivering end-to-end solutions on a scale. Our Salisbury, NC site supports high-growth cloud infrastructure customers—from server and rack integration to data-center subsystems—where quality, speed, and traceability are non-negotiable.

How will you make an impact?

• As the Lead Quality Systems Engineer, you will serve as a guardian of Quality, shaping a Quality Management System that thrives on speed, security, and scalability. 

• This position requires proven experience with developing and implementing QMS in a new start up site. 

• The position also requires the skills to lead cross-functional teams to ensure that our products and processes align with ISO 9001:2015 expectations while still honoring the fast-moving rhythm to meet customer expectations. 

• Quality Systems requires a unique balance of technical precision and practical, streamlined solutions. As a unifying partner across teams, the Quality Systems Engineer provides positive leadership, challenges complacency, and drives continuous improvement—while ensuring processes remain efficient and free of unnecessary administrative burden.

What will you do ?

Quality Management System Leadership

• Establish a strong QMS foundation aligned with Jabil Global QMS and ISO 9001:2015 Standards. 

• Own the Quality Policy and measurable quality objectives throughout the site; monitor performance and drive corrective actions where needed. 

• Lead Management Review processes — ensuring data-driven decision-making and compliance visibility. 

Auditing & Compliance

• Plan and execute internal audits across engineering and operations (with focus on IC, Planning, and other core Manufacturing Processes), product management, customer support. 

• Serve as primary liaison with external auditors, certification bodies, and regulatory partners. 

• Track and ensure closure of nonconformities, corrective actions, and risk mitigations. A strong grip on basics such as FMEA and Control Plan is a plus point. 

• Champion structured problem-solving using 8D, RCA, FMEA, DMAIC or equivalent frameworks. 

Document & Process Ownership

• Own lifecycle management for QMS documentation — including processes, SOPs, Work Instructions, and Quality Records. 

• Partner with system owners to ensure traceability and version control across Jabil document control tools. 

Customer & Stakeholder Focus

• Integrate Voice of Customer (VoC) into QMS improvements and product roadmaps. 

• Lead quality representation in major incident reviews and customer-impacting events. 

• Track quality KPIs and present insights clearly into executive leadership. 

Training & Culture Building 

• Develop and deliver ISO 9001:2015 and QMS awareness training for all functions starting at New Employee Orientation. 

• Advocate for an initiative-taking quality culture — where quality is everyone’s job, not a bureaucratic checkpoint. 

Education:

• Bachelor’s degree in engineering or quality discipline (master’s preferred) 

Experience

• 5–8 years in Quality Engineering or Quality Systems roles; at least 2-3 years in leading Quality Management Systems

• Strong expertise in ISO 9001:2015 implementation and certification maintenance 

• Proven experience with internal and supplier audits 

• Data-driven mindset — Excel/Sheets mastery is preferred; bonus if familiar with BI tools (Power BI, Tableau) 

• Certifications (preferred): CQE, CQA, Lead Auditor, Six Sigma Green/Black Belt Etc. 

What Can Jabil Offer You?

Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:

• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options

• 401K Match

• Employee Stock Purchase Plan

• Paid Time Off

• Tuition Reimbursement

• Life, AD&D, and Disability Insurance

• Commuter Benefits

• Employee Assistance Program

• Pet Insurance

• Adoption Assistance

• Annual Merit Increases

• Community Volunteer Opportunities

How will you make an impact?

Manages through subordinates, the development and maintenance of quality evaluation, control systems and protocols for processing materials into partially finished or finished products for a business unit or corporate. Manages the audits of quality systems for deficiency identification and correction. Manages the overall development of inspection and testing processes, mechanisms and equipment as applied to new or existing products. Direct the design, development and maintenance of quality systems and procedures for processing materials into compute and networking racks for multiple product lines. Key objective for this role is to develop a culture of quality within the organization, drive continuous improvement in quality processes, systems tools, and techniques to improve business results and customer satisfaction. Provide exceptional support to customers, team members, and shareholders.

• Provide input to and support of plant and company safety initiatives

• Provide guidance to support the policies and process with the quality department members to promote the understanding and compliance.

• Establish the short and long-term quality goals for the organization and the team.

• Direct activities to facilitate the interaction between Quality and the other functional operations area, especially test and manufacturing engineering to accelerate improvement.

• Provides early guidance and solution’s concerning quality evaluation, control systems and protocols, e.g., non-compliant situations, customer scalations, requirements, government regulations, accuracy of products.

• Executes all management reports to clients, business unit.

• Collaborates with customer in order of accomplish their requirement’s or for any scalation.

• Development and modification of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements.

• Direct the development of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Provides guidance to statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Directs the auditing process of quality systems for deficiency identification and correction, and delegates to the subordinates the implementation of the corrective action plans and executed in a timely manner.

• Ensures that corrective measures meet acceptable standards, and that documentation is compliant with all Jabil and customer requirements.

• Directs the development of sustainable, repeatable and quantifiable business process improvements. Develops and modifies as necessary and required on the status of quality assurance programs and practices.

• Provide direction and training, as necessary, to a staff of Managers and Quality Assurance Engineers.

• Provides early guidance concerning compliance all site required agency certifications related to product and process quality, not limited to: ISO 9001.

• Establishes up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.

• Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.

• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

• May perform other duties and responsibilities as assigned.

How will you get here?

Education and Experience:

• Bachelor’s degree required. Master’s degree preferred in Engineering or Technology disciplines.

• Minimum ten (10) years of experience and required industry experience

• Or a combination of education, experience and/or training.

• Ideally Seven (7) years of experience in high technology manufacturing including 3 plus years in compute and network server/rack industry.

• Must have a proven track record of driving improvements ideally in compute and network server/rack products.

• Experience in defining and changing quality culture in production environment.

• A team builder: develop and lead a cohesive quality team as well as drive cross functional collaboration.

• Successful track record of working in a matrix/collaborative environment.

• Strong background in ISO-9000 or similar ideally with ground up implementation experience.

• Multisite leadership experience would be a plus.

• Excellent verbal and written communication skills.

• Multi-task management.

• Teamwork and collaboration.

• Strong interpersonal skills.

How will you make an impact?

Manages through subordinates, the development and maintenance of quality evaluation, control systems and protocols for processing materials into partially finished or finished products for a business unit or corporate. Manages the audits of quality systems for deficiency identification and correction. Manages the overall development of inspection and testing processes, mechanisms and equipment as applied to new or existing products. Direct the design, development and maintenance of quality systems and procedures for processing materials into compute and networking racks for multiple product lines. Key objective for this role is to develop a culture of quality within the organization, drive continuous improvement in quality processes, systems tools, and techniques to improve business results and customer satisfaction. Provide exceptional support to customers, team members, and shareholders.

• Provide input to and support of plant and company safety initiatives

• Provide guidance to support the policies and process with the quality department members to promote the understanding and compliance.

• Establish the short and long-term quality goals for the organization and the team.

• Direct activities to facilitate the interaction between Quality and the other functional operations area, especially test and manufacturing engineering to accelerate improvement.

• Provides early guidance and solution’s concerning quality evaluation, control systems and protocols, e.g., non-compliant situations, customer scalations, requirements, government regulations, accuracy of products.

• Executes all management reports to clients, business unit.

• Collaborates with customer in order of accomplish their requirement’s or for any scalation.

• Development and modification of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements.

• Direct the development of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.

• Provides guidance to statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

• Directs the auditing process of quality systems for deficiency identification and correction, and delegates to the subordinates the implementation of the corrective action plans and executed in a timely manner.

• Ensures that corrective measures meet acceptable standards, and that documentation is compliant with all Jabil and customer requirements.

• Directs the development of sustainable, repeatable and quantifiable business process improvements. Develops and modifies as necessary and required on the status of quality assurance programs and practices.

• Provide direction and training, as necessary, to a staff of Managers and Quality Assurance Engineers.

• Provides early guidance concerning compliance all site required agency certifications related to product and process quality, not limited to: ISO 9001.

• Establishes up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.

• Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.

• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

• May perform other duties and responsibilities as assigned.

How will you get here?

Education and Experience:

• Bachelor’s degree required. Master’s degree preferred in Engineering or Technology disciplines.

• Minimum ten (10) years of experience and required industry experience

• Or a combination of education, experience and/or training.

• Ideally Seven (7) years of experience in high technology manufacturing including 3 plus years in compute and network server/rack industry.

• Must have a proven track record of driving improvements ideally in compute and network server/rack products.

• Experience in defining and changing quality culture in production environment.

• A team builder: develop and lead a cohesive quality team as well as drive cross functional collaboration.

• Successful track record of working in a matrix/collaborative environment.

• Strong background in ISO-9000 or similar ideally with ground up implementation experience.

• Multisite leadership experience would be a plus.

• Excellent verbal and written communication skills.

• Multi-task management.

• Teamwork and collaboration.

• Strong interpersonal skills.

• 
  
• Manage the quality department, directing the work of quality technicians to satisfy the quality requirements for the current business and future business improvement.
  
• Develop and execute annual quality goals and objectives that align with overall company goals and long-range strategy plans.
  
• Assure that the Quality System is active and the ISO 9001 registration is maintained with minimal audit findings. This includes the many aspects including management reviews, internal audits, risk assessment and those outlined below.
  
• Provide technical support to manufacturing through the Quality Team.
  
• Participate in any new product introduction or product change projects, assuring that all requisite quality characteristics and requirements are met.
  
• Maintain accurate calibration of all measuring instruments and any tools that require such calibration.
  
• Actively direct the corrective action system for customer complaints/returns, internal processes as well as purchased product and material.
  
• Work with Mfg. Engineering and Maintenance; develop and guide documented evidence of machine and process capability.
  
• Develop training and education for the business in key aspects of quality, including the quality department and new hires.
  
• Lead Receiving Inspection and assist in driving the Supplier Quality Program to improve overall Supplier performance.
  
• Provide management with measurements of our product, process and customer/supplier quality and recommendations for both remedial as well as preventive measures to be taken with alternatives, costs, resources, timing and risk and benefit analysis.
  
• As part of business planning, lead the development of quality plans and improvement plans that have a positive impact on the overall cost of quality.
  
• Manage resources, including budgets, expense recommendations and capital appropriations to ensure effectiveness of the quality system and improve overall gross margins.
  

• 
  
• A bachelor's degree in quality or an engineering discipline.
  
• 10 years of pertinent experience in a manufacturing-based business.
  

• 
  
• Knowledge of quality methods, tools and instruments.
  
• Strong background with ISO 9000 quality system requirements.
  
• Strong problem solving skills.
  
• Ability to develop and implement training for part measurement/inspection, quality systems and TQM methods.
  
• Excellent communication skills.
  
• Computer skills including Microsoft Word, Excel, Power Point at a minimum.
  
• General knowledge of safety and environmental requirements in a manufacturing environment.
  

• 
  
• Physical demands are typical of an office position including extended periods of sitting, extensive use of a personal computer and telephone.
  
• Position requires movement around the facilities.
  
• Occasional handling of material and components
  

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Job Title: Director of Clinical Quality

Location: Modesto, CA

Schedule: Monday–Friday (Director-level role with 24/7 departmental accountability)

Salary Range: $140,000 – $220,000 (DOE)

Relocation: Available based on candidate location and distance

Wheeler Staffing Partners is seeking an experienced Director of Clinical Quality to serve as a senior hospital leader responsible for quality outcomes, patient safety, regulatory compliance, and performance improvement initiatives. This executive-level role reports to the Chief Nursing Officer and is accountable for hospital-wide quality strategy and measurable clinical outcomes.

Position Summary

The Director of Clinical Quality provides strategic leadership for hospital-wide Quality Assessment and Performance Improvement (QAPI) programs. This role ensures delivery of safe, patient-centered, outcomes-based, and cost-effective care while maintaining compliance with accreditation and regulatory agencies.

The Director leads initiatives related to:

• Quality outcomes and performance improvement
• Patient safety programs
• Regulatory and accreditation compliance
• Peer review and risk management
• Infection prevention and control
• Clinical data analysis and reporting

This role requires strong executive presence, analytical expertise, and the ability to lead multidisciplinary teams in a complex hospital environment.

Key Responsibilities

• Develop, implement, and oversee hospital-wide quality and performance improvement programs
• Monitor clinical outcomes and identify opportunities for measurable improvement
• Lead patient safety initiatives and ensure appropriate incident reporting processes
• Ensure compliance with Joint Commission, CMS, state regulatory, and accreditation standards
• Oversee Infection Prevention, Risk Management, Peer Review, and related quality functions
• Analyze hospital data, dashboards, and quality metrics to drive strategic decisions
• Present quality performance reports to executive leadership and medical staff committees
• Lead regulatory survey readiness and accreditation preparation efforts
• Drive culture change initiatives to support high-reliability healthcare practices
• Coordinate multidisciplinary teams to achieve quality benchmarks and performance goals

Minimum Qualifications

Education

• Bachelor’s, Master’s, or Doctorate degree in a health-related field
• OR
• Extensive hospital-based quality leadership experience (7+ years) in quality or performance improvement

Required Experience

• Director or Assistant Director-level leadership experience
• Hospital-based Quality and Performance Improvement leadership
• Experience in:
• Outcomes management
• Peer review
• Risk management
• Patient safety
• Infection prevention
• Direct experience working with:
• The Joint Commission
• Centers for Medicare & Medicaid Services (CMS)
• State regulatory agencies

Required Skills & Competencies

• Strong analytical and statistical skills
• Advanced proficiency in Excel, databases, dashboards, and quality reporting tools
• Ability to interpret clinical and operational data
• Executive-level communication and presentation skills
• Proven ability to lead multidisciplinary teams
• Experience driving change in complex hospital environments
• Knowledge of Quality Improvement Organization (QIO) processes and current quality trends

Physical Requirements

• Prolonged standing and walking
• Ability to lift, position, or push up to 50 pounds
• Manual dexterity and mobility as required in hospital environments

Benefits Overview

Comprehensive benefits package may include:

• Medical, dental, vision, and prescription coverage
• Behavioral health and telemedicine services
• 401(k) with employer match
• Paid time off and leave programs
• Tuition assistance and certification support
• Student loan assistance programs
• Employee Assistance Program (EAP)
• Flexible spending accounts
• Supplemental insurance and financial wellness resources

Benefits eligibility may vary based on employment status and location.

If you are an experienced hospital quality leader with Director-level experience and a strong background in regulatory compliance, patient safety, and performance improvement, apply today to explore this leadership opportunity in Modesto, CA.*

Drive Excellence. Lead Change. Make an Impact.

CHEP, a global leader in sustainable supply chain solutions, is seeking a passionate Operations Quality & Continuous Improvement Supervisor to join our Temple, TX team.

In this pivotal role, you’ll lead quality initiatives, champion continuous improvement, and collaborate across departments to deliver exceptional customer outcomes. You’ll be hands-on in mentoring your team, optimizing plant performance, and ensuring compliance with global standards—all while contributing to a culture of safety and innovation.

Key Accountabilities - What you will do:

• Develops and drives continuous improvement initiatives to ensure that the quality control function meets key performance indicator goals.
• Supervise and coordinate the work of all quality department employees.
• Provide hands-on leadership as a supervisor; responsible for mentoring and coaching all quality employees and working through employee relations issues
• Drives compliance of CHEP quality guidelines at the service center.
• In partnership with Plant Manager, provide leadership to the quality staff to effectively recruit, train, develop, evaluate, motivate, delegate, and monitor their activities.
• Collaborates with plant leadership to ensure compliance to established policies.
• Ensure the consistent execution of all SOPs throughout the Plant in accordance with the QMS, PMS, Commercial Organization, and Global Supply Chain.
• Support cost control initiatives and process control within the Plant.
• Responsible, in consultation with Plant Manager, for the cost and yield performance of the Plan in partnership with the overall P&L of the Plant.
• Deliver best operational practices and cost efficiencies across the Plant while maintaining critical quality and raw material utilization standards that are necessary to maintain customer satisfaction and Plant profitability.
• Ensure compliance through teamwork for all Standard Operating Procedures within the Plant.
• Manages and ensures proper documentation of all quality related documents for all plant personnel.
• Develop, lead, organize group projects targeting quality systems and continuous process improvements. Reports on progress and project deliverables.
• Partners with Regional Quality personnel and the greater quality team to resolve concerns and execute on strategic goals of the organization.
• Collaborates with Plant HSE Supervisor and HSE Plant Lead to support and drive Safety improvements (Zero Harm) across the Plant.
• Conduct and lead Train the Trainer program for all training personnel as it relates to quality.

Qualifications

• Bachelor’s degree is preferred OR relevant business experience

Experience-What You will bring:

• 3-5 years’ experience in Quality Assurance or Continuous improvement specialized role.
• Lean Six Sigma certification(s) preferred
• Prior experience in a plant or quality supervisory role
• Strong customer focus orientation.
• Demonstrated ability to work in a challenging environment.
• Ability to lead a team.
• Ability to give and receive constructive feedback.
• Demonstrated ability to work cross-functionally.
• Understanding of supply chain practices and metrics.
• Knowledge of manufacturing operations, training quality and production employees.
• Knowledge and experience of quality control program implementation.
• Basic knowledge of OSHA standards.
• 3+ year’s line leadership experience.
• Demonstrated ability to communicate effectively with Director and above level leadership.

Skills and Knowledge

• Proven ability to get results through mentoring skills - effective coaching, facilitation & presentation
• Strong communication skills
• Excellent problem-solving skills and strategic thinking ability.
• Data analysis
• Critical thinking
• Organizational and time management skills
• Strong MS Office knowledge and skills including Excel, Word and PowerPoint
• Quality Mindset
• Coaching and delegation
• Conflict Management

Languages

• English - Required
• Spanish - Preferred

What we Offer:

• Competitive Pay
• Benefits Day 1!
• 401K w/ company match (up to 4%)
• FREE company-paid vision, short-term disability, and life insurance!!
• FREE company-provided PPE and safety equipment
• Tuition reimbursement, wellness incentives, parental leave, childcare assistance, profit sharing, and MORE!

Compensation Statement: The salary range for this position is $62,000 to $84,000 per year. Salary ranges provided take into account a wide variety of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications, geographic differentials and other business and organizational needs. Therefore, actual amounts offered may be higher or lower than the range provided. If you have questions, please speak to your Talent Acquisition Partner about the flexibility and detail of our compensation philosophy.

Dependent on the position offered, other forms of compensation may be part of a total offering beyond medical & retirement benefits and may include other monetary incentives or business benefits.

Founded in 1984, Best Formulations LLC, a diversified nutraceutical and personal care company headquartered in City of Industry, California, is a contract manufacturer of thousands of branded SKUs, including high quality nutritional supplements. At the core of our ethos is a dedication to personal care, where every product is crafted with meticulous attention to detail and the highest standards of quality. Our longstanding expertise in contract manufacturing dietary supplements has uniquely positioned us as leaders in research, regulatory compliance, and quality assurance.

About the role:

We are seeking an experienced Quality Executive to lead our Quality Compliance and Quality Control functions within a dynamic lab environment. This role is pivotal in ensuring that all products meet regulatory standards, customer expectations, and internal quality benchmarks. The ideal candidate will champion a Quality by Design approach, fostering a culture of continuous improvement and operational excellence.

How will you contribute:

Quality Compliance:

• Ensure adherence to all relevant regulatory requirements (FDA, GMP, ISO, etc.) for nutraceutical manufacturing.
• Maintain and update quality systems, SOPs, and documentation to meet compliance standards.
• Oversee audits (internal, external, and customer) and manage corrective/preventive actions.

Quality Control:

• Lead and manage QC operations, including raw material, in-process, and finished product testing.
• Ensure robust analytical and microbiological testing processes are in place and validated.
• Collaborate with R&D and production teams to resolve quality issues promptly.

Strategic Leadership:

• Develop and implement a Quality by Design framework across all processes.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Build and mentor a high-performing quality team.

Minimum Requirements/Qualifications:

• Bachelor’s or master’s degree in quality assurance, Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 8+ years of experience in Quality roles within nutraceutical, pharmaceutical, or food manufacturing industries.
• Previous experience in dietary supplements manufacturing, specifically with soft gel dosage forms, is highly preferred.
• Strong knowledge of regulatory requirements (FDA, GMP, ISO standards) and other regulatory frameworks relevant to nutraceutical manufacturing.
• Proven experience in managing audits and compliance programs.
• Familiarity with analytical and microbiological testing methods.
• Excellent communication, interpersonal, and organizational skills.
• Certifications preferred: ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Preventive Controls Qualified Individual (PCQI) or other relevant quality or regulatory certifications.

Work Environment:

• May involve exposure to allergens such as Soy, Wheat, Fish, Shellfish, Milk, Egg, Tree Nuts and Sesame.

More about us:

As a valued strategic partner, Best Formulations offers a comprehensive program of services, turnkey solutions, and client support that is unmatched in the industry. Our product development team can provide customized, proprietary formulations designed specifically to meet the needs of our customers and their method of distribution. Our vertically integrated manufacturing and packaging process allows us to schedule flexible production runs to respond quickly to shifting market demands. Every step of the way, we are committed to your growth and success!

"To develop and strengthen mutually beneficial relationships with our employees, customers, and business partners by providing the highest quality products and the Best customer service. Together We Grow!"

EEO Statement

Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.

Kelly is hiring for a Specialist - Quality Control for a 12-month contract role at Chesterfield, MO 63017 with our prestigious client.

Job Title: Specialist - Quality Control/ Quality Coordinator

Primary Location: 16401 Swingley Ridge Rd Ste 700, Chesterfield, MO 63017

12-month contract - Onsite role

Shift: 8:00 AM to 4:30 PM

Pay rate: $30-38.50/hr.

Summary: The Laird Chesterfield site is seeking a Quality Coordinator. Laird designs, develops and delivers industry leading solutions that protect electronics to enhance the performance and reliability for our customers. Our global organization of world-class scientists and engineers provide solutions to our existing and future customers’ complex problems. A successful candidate will lead the Chesterfield location’s Quality Management System requirements as well as key improvement programs, including support for automotive and aerospace manufacturing sites across Laird. This specific location is not a manufacturing site but includes processes and activities such as Sales, Quoting, Customer Service and some Product Design. Other activities related to quality include but are not limited to system implementation, standardization, and automation. The Quality Coordinator will ensure that the organization’s Quality Management System conforms to internal, Quality Standard requirements (ISO 9001 and others), customer requirements, and any applicable regulatory/legal requirements. The role will collaborate with site leadership, business leadership, and Laird Quality Leaders to ensure compliance and drive continual improvement of the Chesterfield QMS. This position will report to the Laird North America Quality Leader.

RESPONSIBILITIES

• Implementation, support, and improvement of the Quality Management System (QMS) for this site.

• Maintain site metrics and communicate with business and quality leaders on site quality performance; review recommend areas for focus and attention

• Support QMS interfaces with other Manufacturing sites; this location is a remote support location for other sites

• Maintain and improve conformance to applicable Quality Standard requirements including ISO 9001, IATF 16949, AS9100 etc.

• Coordination of and participation in QMS audits by 3rd party Certification Bodies (CB); act as liaison between site team and CB

• Coordinate, maintain and improve internal audit program in compliance with Quality Standards and any relevant customer specific requirements

• Coordinate Management Review activities for Chesterfield and support of other manufacturing sites

• Conduct training on QMS procedures as required and maintain associated records

• Improve and maintain documented information control activities, including revision of the Quality Manual, development of document reviews, and control of related records

• Lead Corrective Action activities; monitor completion of assigned investigations and corrective actions; conduct verification of effectiveness

• Lead investigations on internal and 3rd party NCs; improve and maintain employee competence in problem solving

• Coordinate and track continual improvement projects; evaluate effectiveness to customer or business goals/impact

• Analyze data and trends in support of QMS processes and other site activities such as customer service, customer satisfaction, complaints, or quoting

• Support the Document Change Management process for the Chesterfield site

• Additional administrative responsibilities and support for other functions at the site as needed

REQUIREMENTS

• Proficient knowledge of ISO 9001 (minimum), IATF 16949 and AS9100D desirable

• Good communication skills, both written and oral.

• Ability to maintain accuracy and attention to detail.

• Ability to work as an individual contributor or in a team environment.

• Experience performing Internal Audits

• Experience with CAPA systems

EDUCATION / EXPERIENCE

• Bachelor’s degree in a related field (Quality Mgmt., Operations, Manufacturing Mgmt., etc.)

• Minimum 7-10 years’ experience working within and/or managing a QMS certified to ISO 9001:2015 (IATF 169949 desired)

• Lead or Internal Auditor certification for ISO 9001:2015 and/or IATF 16949:2016 (desired)

• Ability to understand relevant industry controls and requirements in support of manufacturing support processes to achieve and maintain compliance with relevant Standards

• Leadership and project management skills to drive improvement projects

• Root Cause/Corrective Action training and experience

• Proficiency in Microsoft Office applications and any other relevant systems for the management of documents, corrective actions, projects, etc.

If you feel this role interests you, feel free to apply or refer someone who would be a good fit.

Job Title: Director of Quality Assurance – Tissue Processing

Location: San Antonio, Texas, USA

Department: Quality Assurance / Regulatory Affairs

Reports To: Executive Leadership

FLSA Status: Exempt

Position Summary

The Director of Quality Assurance is responsible for providing strategic leadership, direction, and oversight to the company’s Quality Management System (QMS) to ensure compliance with international and domestic tissue processing regulations, standards, and corporate policies. This role establishes quality strategy, directs organizational compliance programs, and ensures alignment with corporate objectives across all quality assurance processes, including regulatory compliance, internal and external audits, risk management, supplier quality, and continuous improvement initiatives. The Director of Quality Assurance serves as a key member of the leadership team, providing executive-level guidance on quality strategy and regulatory risk management, ensuring the delivery of safe and effective products that meet or exceed customer and regulatory requirements.

Essential Duties and Responsibilities

• Lead the implementation, maintenance, and improvement of the QMS in compliance with cGMPs, ISO 13485:2016, ISO 14971:2019, and FDA 21 CFR:

Part 11 (Electronic Records; Electronic Signatures), 

Part 820 (QSR)

Parts 361/1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products)

And the relevant FDA Guidance documents for these regulations

• Provide oversight of product release strategy and ensure compliance through delegated authority.
• Establish and oversee policies for raw material acceptance, supplier controls, and product disposition.
• Ensure organizational compliance with labeling and packaging requirements through policy, audit, and review.
• Plan, manage, and resource internal audits, supplier audits, and regulatory inspections; serve as the host and primary point of contact for regulatory and notified body representatives.
• Assure programs related to document control, GMP training program, and controlled record management are in compliance.
• Direct Quality approval for the CAPA process, including nonconformance handling, root cause analysis, corrective/preventive action planning, and effectiveness verification.
• Provide oversight and guidance for product risk management in accordance with ISO 14971.  Perform the quality review function for device pFMEA/dFMEAs and design control through delegation to appropriately trained and qualified staff.
• Review and approve quality-related documentation, including validation protocols, verification reports, design control deliverables, and batch records.
• Develop the key quality metrics for the periodic QMSR (Quality Management Systems Review) to drive systemic improvements, enhancing compliance and operational effectiveness.  
• Develop, mentor, and direct the Quality team and oversee staff development across multiple quality functions to ensure alignment with company goals and regulatory expectations.
• Partner with cross-functional teams (Process Engineering, Manufacturing, Warehouse/Distribution, Regulatory Affairs, Operations, Sales) to support quality throughout the product lifecycle.
• Competency and proficiency in making standard Regulatory submissions, updates, and communications, such as FDA Establishment Registrations, 510k’s, State Registrations, and FSCA for Medical Devices. 
• Ability to guide the organization to compliantly launch new medical device products and configurations to market

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field; advanced degree strongly preferred.
•  Minimum of 10–12 years of progressive experience in tissue processing quality assurance, with at least 5+ years in a director-level or equivalent leadership capacity.
• Comprehensive knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and EU MDR.
• Demonstrated experience and favorable outcomes with FDA inspections, notified body audits, and supplier quality programs.
• Expertise in QMS software platforms and document control systems.
• Strong analytical, problem-solving, and decision-making skills. 
• Professional certifications CQA, CQE, LSSBB, or RAC.

Competencies

• Executive leadership and organizational management skills
• Regulatory compliance expertise
• Effective communication and presentation abilities, including executive reporting and Board-level communication
• Strong attention to detail
• Continuous improvement mindset
• Demonstrated ability to mentor and coach staff and peers

Work Environment & Physical Requirements

• This position operates in a professional office and/or manufacturing environment.
• Regular use of computers, phones, and office equipment.
• May require occasional lifting of materials up to 25 pounds.
• Exposure to manufacturing floor environments.

Travel Requirements

• Occasional domestic travel may be required (estimated 20%) to support audits, supplier evaluations, and regulatory inspections.

Compensation & Benefits

• Competitive base salary commensurate with experience.
• Performance-based annual bonus eligibility.
• Comprehensive benefits package, including medical, dental, vision, life insurance, and 401(k) with company match.
• Paid time off, sick leave, and company holidays.
• Professional development opportunities and continuing education support.

Our client is seeking an experienced Plant Quality Manager to oversee and manage the quality assurance processes at their automotive manufacturing facility. The successful candidate will lead a team of quality engineers, technicians and coordinators ensuring the highest standards of quality are maintained throughout the production process. This role is critical in driving continuous improvement initiatives and maintaining compliance with industry standards and customer requirements. FULL RELOCATION ASSISTANCE IS AVAILABLE!

Key Responsibilities:

- Lead and manage the plant quality department, including a team of quality engineers, to ensure quality objectives are met.

- Develop, implement, and maintain quality assurance systems and processes to ensure product quality and compliance with industry standards and customer specifications.

- Collaborate with cross-functional teams, including production, engineering, and supply chain, to identify and resolve quality issues.

- Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.

- Monitor and analyze quality performance metrics, preparing reports and presenting findings to senior management.

- Oversee the auditing process of internal systems and processes to ensure compliance with ISO standards and other relevant regulations.

- Manage customer quality concerns and lead problem-solving efforts to address and resolve issues promptly.

- Develop and maintain strong relationships with key customers and suppliers to ensure quality expectations are met and exceeded.

- Train and mentor quality engineers and production staff on quality standards, procedures, and best practices.

- Stay updated on industry trends, advancements, and regulatory changes to ensure ongoing compliance and competitiveness.

What we are seeking:

- Bachelor’s degree in Engineering, Quality Management, or a related field. Advanced degree preferred.

- Proven experience in quality management within the automotive industry preferred.

- Strong leadership skills with a track record of effectively leading and developing a team of quality engineers.

- In-depth knowledge of quality management systems, ISO standards, and automotive industry standards (e.g., IATF 16949).

- Excellent problem-solving and analytical skills with the ability to drive root cause analysis and corrective actions. (PPAP, PFEMA, etc)

- Strong communication and interpersonal skills, with the ability to collaborate effectively across all levels of the organization.

- Proficient in quality management software and tools.

- Certification in quality management (e.g., Six Sigma, ASQ CQE) is a plus.