Aac Best Quality Jobs in Usa
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Founded over 35 years ago, First Quality is a family-owned company that has grown from a small business in McElhattan, Pennsylvania into a group of companies, employing over 5,000 team members, while maintaining our family values and entrepreneurial spirit. With corporate offices in New York and Pennsylvania and 8 manufacturing campuses across the U.S. and Canada, the companies within the First Quality group produce high-quality personal care and household products for large retailers and healthcare organizations. Our personal care and household product portfolio includes baby diapers, wipes, feminine pads, paper towels, bath tissue, adult incontinence products, laundry detergents, fabric finishers, and dishwash solutions. In addition, we manufacture certain raw materials and components used in the manufacturing of these products, including flexible print and packaging solutions.
Guided by our values of humility, unity, and integrity, we leverage advanced technology and innovation to drive growth and create new opportunities. At First Quality, you’ll find a collaborative environment focused on continuous learning, professional development, and our mission to Make Things Better®.
We are seeking a Quality Assurance Manager for our First Quality Retail Services facilitylocated in Lewistown, PA.
This position will be responsible for the creation, implementation and monitoring of all corporate & site Quality practices within their site of operation. Leading a team of quality professionals and driving a culture of continual improvement. Play a pivotal role and work collaboratively within the site management team, and drive quality engagement through all levels of the organization.
Primary responsibilities include:
- Provide leadership and planning to develop, implement and maintain quality systems to ensure compliance to regulatory, industry, and customer standards.
- Serves as the Management Representative for all site compliance and quality systems
- Supervises the activities of assigned staff and monitor the activities of QA/QC personnel within the QA Department.
- Assure that all resources utilized for the quality functions are procured, maintained, and perpetuated in a cost effective and timely manner within the goals of the strategic business plan.
- Take the leadership role in maintaining/changing the quality culture of the company – serve as the visible model of Quality. Educate team members in the quality philosophy and practices, including improvement strategies.
- Represents the company to vendors, customers, and appropriate regulatory officials in matters related to quality.
- Administers the quality audit program.
- Provides training to team members, as required, for implementing quality initiatives.
- Work with cross-functional teams to prioritize key site projects and determine appropriate resources and timing; integrate lean six sigma activities with quality system activities such as Corrective and Preventive Action (CAPA) and Quality Improvements to assure effectiveness and compliance to customer and regulatory requirements.
- Develops annual quality plans and recommendations for continual improvement in conjunction with the Quality Leader and Operations Manager
- Determines methods and implements plans for professional development of personnel within the QA Department.
- Proposes budgets and monitors budget activity for the QA Department.
- Provides statistical analysis for evaluation of processes, and issue KPI reports to site leadership and divisional leaders at determined frequencies.
- Conducts lab tours and explains quality system to visitors.
- Understands competitive product features in comparison to products.
- Completes required reports and summaries for regulatory & industry agencies.
- Assists and substitutes for the Divisional Quality Leader, as needed.
- Observes all safety rules and always uses the proper safety equipment.
- Performs other duties as necessary when directed to do so.
- Follows necessary GMP, FDA, and ISO regulations.
- Manage master validation plan.
- Implement, monitor and review online Quality systems, including vision QMS Software, and SPC systems.
The ideal candidate should possess the following:
- Bachelor’s degree in an Engineering, Technology, Mathematics, Business, or Science discipline.
- Three years minimum experience as a Quality Manager, Technical Manager, or QC Supervisor in a manufacturing environment (preferably FDA-regulated environment).
- Six sigma Green Belt certified, preferred.
- Supervisory experience.
- Auditing experience in GMP and/or ISO systems.
- ASQ Certification or equivalent training (CQE, CQA, CQT, or CQM).
- Advanced skills in oral and written communications.
- Standard skills in technical, business, and managerial fields.
- Standard skills in statistics, procedure implementation, and quality auditing.
- Competent in interactions with executive management, vendors, and customers.
What We Offer You
We believe that by continuously improving the quality of our benefits, we can help to raise the quality of life for our team members and their families. At First Quality you will receive:
- Competitive base salary and bonus opportunities
- Paid time off (three-week minimum)
- Medical, dental and vision starting day one
- 401(k) with employer match
- Paid parental leave
- Child and family care assistance (dependent care FSA with employer match up to $2500)
- Bundle of joy benefit (year's worth of free diapers to all team members with a new baby)
- Tuition assistance
- Wellness program with savings of up to $4,000 per year on insurance premiums
- ...and more!
First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.
First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.
For immediate consideration, please go to the Careers section at complete our online application.
Company Description
Automotive Quality & Logistics Inc. (AQL-Inc) is an industry leader specializing in sorting, inspection, containment, light manufacturing, assembly, kitting, rework, engineering support, supplier development, warehousing, and launch support services for automotive and manufacturing businesses. The company is dedicated to achieving 100% customer satisfaction by delivering high-quality products at competitive costs with reliable, on-time delivery. With over 600 trained employees across 16 US states and 1 Canadian province, AQL-Inc proudly supports over 400 automotive companies, including major OEMs like GM, Ford, Chrysler, Toyota, Mercedes, and Honda. AQL’s ISO 9001:2000 certification reflects its strong commitment to quality, and as a woman-and minority-owned business, it is dedicated to fostering growth by investing in its workforce and strengthening partnerships in the automotive supply chain.
Role Description
This is a full-time, on-site position based in Plymouth, MI, for a Quality Operations Manager. The role involves overseeing day-to-day quality operations, ensuring compliance with quality standards and processes, and managing quality control initiatives. The individual in this role will coordinate inspections, monitor quality assurance practices, lead quality audits, and collaborate with internal teams and external stakeholders to meet operational and customer objectives. Additional responsibilities may include process improvement, reporting metrics, and training team members in quality management practices.
Qualifications
- Experience in Operations Management to successfully oversee and optimize daily business activities and processes.
- Proficiency in Quality Control, Quality Auditing, and Quality Assurance to ensure processes meet or exceed compliance and customer expectations.
- Strong expertise in Quality Management to develop and implement strategies that enhance operational efficiency and product quality.
- Exceptional problem-solving abilities and analytical skills to identify and address quality issues effectively.
- Excellent leadership and communication skills to manage teams, collaborate with stakeholders, and drive organizational success.
- Relevant professional certifications such as Six Sigma, ISO compliance, or similar, are highly preferred.
- Travel required position - up to 70% of time.
- Previous automotive industry experience preferred.
The Manager of Quality Assurance is responsible for overseeing the Quality Department to ensure compliance with ISO 9001 standards and company quality objectives. This role manages quality staff, supports manufacturing operations, and drives continuous improvement initiatives. Key responsibilities include maintaining quality systems, leading audits, supporting new product introductions, managing corrective actions, and monitoring supplier performance. The Manager of Quality Assurance also develops training and reports on quality metrics, and manages departmental resources to improve product quality, customer satisfaction, and overall business performance. This is a working manager role requiring the incumbent to both lead the quality function and directly perform hands-on quality engineering and assurance activities as the business needs dictate.
PRINCIPAL DUTIES AND RESPONSIBILITIES (ESSENTIAL FUNCTIONS)
- 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.
EDUCATION AND EXPERIENCE
- A bachelor's degree in quality or an engineering discipline.
- 10 years of pertinent experience in a manufacturing-based business.
KNOWLEDGE, SKILLS AND ABILITIES
- 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
- 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
WORKING CONDITIONS
Normal manufacturing and office environment. When working occasionally in some shop areas, personal protection equipment (PPE) will be recommended and/or required (safety shoes, safety glasses w/side shields, hearing protection, face shield, gloves, apron and boots). Must have the ability to support extended business hours to meet customer business needs.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
QUALITY
Quality encompasses all aspects of DeZURIK, Inc.'s business, and every team member shares the responsibility to prevent the occurrence of any nonconformity relating to product, process, and the quality system. All team members have an obligation to identify and record any such nonconformity, and, through designated channels, initiate and recommend solutions.
SALARY AND BENEFITS
DeZURIK offers a competitive base salary in the $98,221 to $122,776 range, based on experience and qualifications, along with annual bonus opportunities tied to performance.
Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. DeZURIK also provides a health savings account with company match, a retirement plan for employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it's needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.
Please note: Sponsorship is not available for this role.
#LI-JW1
It All Starts with Our People
As the leader in automotive preventive maintenance, Valvoline has a proven track record of growth. We continue to invest in our people, processes, and technology to strengthen our ability to efficiently deliver Quick, Easy, Trusted service across all our stores – every day. We're not just in the car business; we're in the people business. And we're looking for humble, hungry, and smart people to help us shape the future of mobility. If you're hungry to drive change and seek a dynamic, collaborative environment that fuels both personal and professional growth, you've found your place with us.
Our highest priority is creating a welcoming workplace with team members from a wide variety of diverse backgrounds and experiences.
How You'll Make a Difference
Valvoline has a rewarding opportunity as a Director, Quality Engineering. In this role, you’ll be a strategic and hands-on leader who will drive the transformation of quality across our technology organization. This leader will be responsible for building and scaling a modern Quality Engineering function that goes beyond traditional QA, with ownership spanning QA environments, test automation, AI-enabled quality practices, quality governance, best practices, and the establishment of a Quality Engineering Center of Excellence (COE).
The ideal candidate will bring a strong blend of leadership, technical depth, operating model design, and change management, with the ability to embed quality throughout the software development lifecycle. This role will partner closely with Engineering, Product, Architecture, Infrastructure, Security, and Delivery teams to create a scalable, efficient, and forward-looking quality strategy that supports speed, reliability, and business growth.
Key Responsibilities
Quality Engineering Strategy & Leadership
- Define and lead the enterprise Quality Engineering vision, strategy, and roadmap aligned to Valvoline’s broader technology and business priorities.
- Shift the organization from traditional testing approaches to a modern quality engineering model focused on prevention, automation, continuous validation, and measurable quality outcomes.
- Establish quality as a shared responsibility across product, engineering, and delivery teams while maintaining strong governance and standards.
- Lead, mentor, and grow a high-performing team of quality engineers, automation engineers, and QA leaders.
QA Center of Excellence (COE)
- Build and operationalize a Quality Engineering Center of Excellence (COE) to define frameworks, standards, tooling, reusable assets, and governance processes.
- Create enterprise-wide best practices for test design, automation, environment strategy, defect management, release readiness, and quality metrics.
- Standardize quality processes across portfolios while allowing for flexibility based on product and platform needs.
- Develop playbooks, templates, training, and maturity models to improve quality capability across teams.
Automation & Tooling
- Define and execute an enterprise test automation strategy across UI, API, integration, data, regression, performance, and end-to-end testing.
- Drive adoption of scalable automation frameworks and ensure integration with CI/CD pipelines and DevOps practices.
- Evaluate, select, and optimize quality tools and platforms to improve speed, coverage, traceability, and reporting.
- Increase automation efficiency and effectiveness by implementing reusable components, common libraries, and engineering best practices.
AI-Enabled Quality Engineering
- Lead the adoption of AI and intelligent automation within quality engineering, including opportunities such as:
test case generation
intelligent defect triage
predictive risk analysis
self-healing automation
release quality insights
test optimization and prioritization
- Assess emerging AI capabilities and define practical use cases that improve quality outcomes, team productivity, and speed to market.
- Partner with engineering and architecture leaders to ensure AI solutions are implemented responsibly, securely, and at scale.
QA Environments & Test Data Management
- Own the strategy for QA environments, including environment planning, availability, stability, governance, and optimization.
- Partner with infrastructure and platform teams to improve environment readiness, reduce bottlenecks, and support parallel delivery.
- Establish strong processes for test data management, environment provisioning, and integration dependency coordination.
- Drive improvements in environment monitoring and readiness reporting to reduce delays and improve release confidence.
Governance, Metrics & Best Practices
- Define and implement quality KPIs, SLAs, dashboards, and scorecards to provide visibility into quality performance, automation maturity, defect trends, release risk, and environment health.
- Set standards for quality gates, entry/exit criteria, defect leakage reduction, root cause analysis, and continuous improvement.
- Build a culture of measurable quality and operational discipline through governance routines, audits, and executive reporting.
- Ensure best practices are embedded into agile delivery, DevSecOps, and release management processes.
Sourcing & Vendor Management
- Define the sourcing strategy for quality engineering capabilities, including the right balance of internal talent, strategic partners, and offshore/onshore vendor models.
- Lead vendor evaluation, selection, governance, and performance management related to quality engineering and testing services.
- Optimize spend, capability, and service quality across external partners while ensuring alignment to Valvoline standards and delivery expectations.
- Build workforce strategies that support both immediate delivery needs and long-term capability development.
Cross-Functional Partnership
- Partner with Product, Engineering, Infrastructure, Security, Architecture, and PMO leaders to embed quality into planning, design, development, and release processes.
- Influence senior stakeholders on quality investments, transformation priorities, and operating model improvements.
- Support mission-critical initiatives by ensuring strong quality planning, risk management, and execution.
What You’ll Need to Succeed
Qualifications
- 10+ years in software quality engineering
- 5+ years leading enterprise QA teams
- Experience in high-volume retail, omnichannel, or consumer-facing environments strongly preferred
- Deep experience with:
Automation frameworks (Selenium, Cypress, Playwright, etc.)
API testing tools
CI/CD tools
Performance testing tools (JMeter, LoadRunner, etc.)
- Experience leading QA in Agile/SAFe or hybrid environments
- Experience using agentic tools for test development and integrating work with agentic code development (ie: Github Copilot, Claude code)
- Proven track record reducing defect escape rates
Leadership Competencies
- Enterprise systems thinker
- Data-driven decision maker
- Builder of scalable processes
- Collaborative but boundary-setting partner
- Comfortable operating in fast-paced retail cycles
- Must be authorized to work in the U.S.
We Take Care of the WHOLE You
- Health insurance plans (medical, dental, vision)
- HSA and flexible spending accounts
- 401(k)
- Incentive opportunity*
- Life insurance
- Short and long-term disability insurance
- Paid vacation and holidays*
- Employee Assistance Program
- Valvoline Instant Oil Change discounts
- Tuition reimbursement*
- Adoption assistance*
*Terms and conditions apply, and benefits may differ depending on position.
Your Path to Valvoline
Valvoline provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Join us in revolutionizing the automotive aftermarket industry while enjoying competitive benefits, a supportive work culture, and opportunities for advancement. Apply now and become an integral part of our journey at Valvoline.
The Company endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided upon request to applicants with disabilities to facilitate equal opportunity throughout the recruitment and selection process. Please contact Human Resources at 1.833.VVV.Report or email to make a request for reasonable accommodation during any aspect of the recruitment and selection process. The contact information is for accommodation requests only; do not use this contact information to inquire about the status of applications.
Company Background
Hayward Tyler, Inc. is a fabrication and engineered solutions company primarily engaged in serving the commercial nuclear power market. We design and manufacture OEM replacement parts, pressure vessels, heat exchangers, strainers, pumps, valves, structural supports and many other products. Offering both build to print and engineered to order integrated solutions, we have the highest level of certifications in the field including ASME code N, NPT, NS, NA, U, and NBIC R and NR.
Role Summary
Reporting to the Quality Assurance Director, the Quality Assurance Supervisor has day-to-day responsibility over the Hayward Tyler, Inc.’s [Nuclear] Quality Program that includes execution of our processes and procedures that define the way we meet the requirements of the Nuclear Regulatory Commission (NRC), ASME B&PV Code, and US Law to ensure our products and services meet the most stringent quality expectations of our customers. This important role is also responsible for the oversight of the output and training of the Quality Control Inspection team. The Quality Assurance Supervisor can also be part of increasing efficiency of HTI through continuous improvement.
Functional Goals
• Facilitation of the HTI Quality Program.
• Successful completion of audits from regulators, certifying organizations, and customers.
• Participates in vendor audits/surveys as required.
• Witnessing vendor activities as required.
• Qualification of Quality Control inspectors.
• Qualification of Quality Assurance personnel.
• Functions as an Authorized Nuclear Inspector interface with the company.
• Along with the Quality Assurance Director, the supervisor reviews the applicable ASME B&PV Code Sections and can make suggestions for changes to the QA Manual for future implementation and improvements as necessary.
• Reports on a regular basis to the Quality Assurance Director on the status and adequacy of the QA program.
• Strives for department deliverables to be right first time.
• A champion for building Quality into all aspects of the business.
• Provides back-up to Quality Assurance Director on all key functions.
Principal Duties
Site Leadership
The Quality Assurance Supervisor serves as the primary Quality contact at the Vermont site, working closely with cross-functional teams, while reporting to the Quality Assurance Director at Hayward Tyler, Inc. in Vermont. This position oversees all QA activity at the Vermont facility, and ensures compliance with company quality standards, regulatory requirements, and customer expectations. Keep management informed of the status of QA issues impacting production, personnel, and product deployment.
Quality Activities
This position leads the Quality department at Hayward Tyler and is responsible for all Quality activities. Quality functions break down into three main areas:
• Quality Assurance
Works with the QA Director to develop and maintain the Quality Program, including the Quality Manual, Policies, Procedures, and Processes to adhere to the requirements of the Nuclear Regulatory Commission, ASME Boiler and Pressure Vessel Code, and US Law. Ensures that quality requirements for contracts are properly converted to internal actionable items, and that the ASL and vendor qualifications are audited to meet our stringent requirements. Responsible for maintaining the qualification and certification of inspectors, internal/external auditors, nondestructive examiners and welders.
• Quality Control
Responsible for the review, the control, and to assure the product and the processes for quality are followed in accordance with our program. This includes contract and supplier purchase order review, material control, calibration, product inspection, destructive and non-destructive testing, and ASME B&PV Code activities.
• Quality Improvement
Responsible for working with the QAD to drive down the cost of quality from both internally and externally manufactured products and services. Major focus is internally generated errors and warranty costs. Responsible for driving a “right the first time” culture.
The Quality Assurance Supervisor also participates in the efforts to recruit, train, review, and mentor the Quality staff. They also may represent Hayward Tyler and its commitment to Nuclear Quality on ASME Committees, NIAC and other nuclear industry organizations and events.
Minimum Qualifications:
• AS in Engineering or equivalent job experience (2 plus years in technical position)
• Work experience in a Quality Assurance role in the commercial nuclear industry preferred.
• Commercial Nuclear audit experience required with Lead Auditor qualification preferred.
• ASQ Certified Quality Engineer, or Auditor is a plus.
• Fundamental understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
• Capability to learn and develop NDE experience from the organization.
• ASME B&PV Code experience in Section III and/or Section VIII preferred.
• Developed understanding of problem-solving and quality improvement tools and techniques. This includes knowledge of planning tools, quality tools, preventive and corrective actions, and how to overcome barriers to quality improvements.
• Fundamental understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems and professional ethics.
• Fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements.
• Ensures that work/escalated issues are addressed and completed in a timely manner and that delays and revised time frames are communicated.
• Ability to read & interpret ASME Code, engineering drawings, standards and specifications.
• Expected travel is up to 15% yearly.
• Proficient in Word, Excel, PowerPoint, Outlook and the Internet.
• Strong leadership, interpersonal, analytical and problem-solving skills.
• Highly ethical, collaborative, detail oriented, organized and highly motivated.
• Other duties as required.
Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation.
We are currently seeking a highly motivated and detail-oriented VP of Quality and Compliance to join our team in the mission to restore vision to patients. This role will report to the Chief Development Officer
The selected candidate will work closely with our Clinical and CMC teams and establish the Quality Department. The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and/or Quality Control functions. The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement and will require 15-20% domestic travel to our contract development and manufacturing organizations in the United States.
Position Overview:
The VP of Quality and Compliance provides strategic and operational leadership for the Quality Assurance and Quality Control functions. They are responsible for leading all quality control systems, regulatory compliance, and safety, ensuring products/services meet industry standards. They are responsible for clinical and CMC quality requirements, vendor management, internal and external compliance, and ensuring that AAV drug substance and product manufacturing, testing, and release meet FDA, EMA, and ICH regulatory standards, from clinical stage to commercialization.
The Vice President of Quality will establish, lead and develop the quality function, in line with the company's stage, while ensuring global regulatory, industry, and corporate standards are met. Reporting to the Senior Vice President of Regulatory Affairs this position will ensure the organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPV). This is a hands-on, strategic, and leadership role, ideal for a seasoned Quality executive passionate about small-molecule therapeutics in a dynamic biotech environment.
Essential Duties and Responsibilities:
- Oversee GXP and Data Integrity activities across various entities, investigator sites, clinical CROs and CMC CDMO’s
- Maintain efficient systems and processes that ensure RayTx and its vendor network comply with GXP standards
- Ensure the appropriate identification, evaluation, and management of risks associated with quality
- Build strong relationships with stakeholders, representing the company's interests and ensuring compliance with all relevant regulations
- Work closely with cross-functional teams to ensure that quality considerations are incorporated throughout the product development lifecycle
- Manage quality-related activities related to manufacturing, clinical trials, and nonclinical studies, including conducting audits of vendors and sites, providing support during health authority inspections, and offering guidance on quality issues
- Lead quality investigations and approve plans to address quality issues that impact products, as well as supervising corrective and preventive actions (CAPAs) for deviations and investigations
- Overseeing the development, implementation, and upkeep of quality systems and procedures, training records, batch records, quality metrics, standard operating procedures (SOPs) pertaining to GXP activities
- Prior experience establishing a Quality Department and growing a group.
- Strong knowledge and understanding of clinical trial design.
- Quality Management System (QMS) Oversight:Develop, implement, and maintain robust quality systems, including document control, change control, deviation management, and CAPA (Corrective and Preventive Actions).
- Provide expert quality oversight on AAV manufacturing processes, analytical method validations, and comparability studies.
- Prior experience developing GCP / GMP auditing plans.
- Regulatory Compliance: Ensure site compliance with global regulations (FDA, EMA) and lead audit readiness efforts (internal and external inspections).
- Batch Disposition: enact internal quality reviews of GMP batch records, and management of finalization and release of clinical or commercial AAV vectors.
- Vendor Management: Oversee quality agreements and audits for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CRO’s).
- Team Leadership: Mentor and lead quality personnel, fostering a culture of quality, safety, and operational excellence
Qualifications and Experience:
- Minimum bachelor's degree in relevant scientific or engineering discipline.
- 8+ years relevant biotech experience.
- Experience in GMP AAV gene therapy manufacturing preferred.
- Knowledge of AAV analytical methods and testing preferred.
- Experience working with CDMO, CRO’s, and other external vendors preferred.
- Experience with clinical quality oversight, SOP generation
- Experience with vendor management and audit planning
- Excellent scientific knowledge and acumen.
- Familiarity with regulatory requirements and documentation
- Ability to travel up to 20%
Compensation Range and Benefits:
- The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
- Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.
All employment is decided on the basis of qualifications, merit, and business need.
Search Firm Representatives Please Read Carefully
Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.
The Legacy nursing philosophy focuses on patients and their families. Our nurses embody this philosophy in everything they do, as advocates, communicators, problem-solvers and caregivers. Their expertise is sought after and respected by our health care team. In short, they are the face of wellness at Legacy. Does this sound like an environment in which you could thrive? If so, we invite you to consider this opportunity.
Responsibilities:The Nursing Practice and Quality Specialist serves as a clinical and operational expert in advancing nursing practice, patient safety, and quality outcomes. Guided by the NAHQ Healthcare Quality Competency Framework, this role supports the design, implementation, and evaluation of nursing practice standards, policies, and quality improvement initiatives that foster excellence in patient care, regulatory compliance, and continuous learning.
Critical Care Expertise:
- Must have knowledge of medical and surgical critical care and trauma processes and procedures
- Experience as a Neurological and Trauma nurse or nurse leader
- Experience with Code Blue and Rapid Response Teams
- Experience leading large multidisciplinary workgroups overseeing the system standards
Quality Leadership and Integration
- Champion a culture of quality and safety across Legacy Health through education, data transparency, and staff engagement.
- Collaborate with nurse leaders and providers to align nursing goals with organizational quality and strategic priorities.
- Serve as a resource for evidence-based practice
- Leads providers, managers and staff in implementation, compliance, and evaluation of clinical standards and evidence-based practice initiatives.
- Lead system-wide initiatives to reduce harm and improve clinical outcomes
Performance and Process Improvement
- Lead and facilitate interdisciplinary quality improvement (QI) projects using the PDSA methodology.
- Will represent a multi hospital view of system wide standardized processes and practices
- Analyze clinical processes, identify performance gaps, and implement improvement plans that enhance outcomes and efficiency.
- Monitor progress through data collection, dashboards, and feedback loops to ensure sustainability of improvements.
- Collaborates with providers, nurses and other clinical disciplines in the implementation, compliance, and evaluation of evidence-based clinical standards.
- Leads and participates in taskforces, committees or councils related to process improvement and provision of quality, evidence-based care.
- Uses Lean tools and principles to improve quality of workflow and patient care.
- Supports clinical practice initiatives to reduce harm, improve quality of care and meet clinical compliance requirements.
- Consults with Nursing Professional Development Specialists in the implementation of evidence-based practice.
- Promote a culture of safety, transparency, and continuous learning throughout the organization.
Patient Safety and Regulatory Readiness
- Coordinate safety initiatives, root cause analyses, and failure mode and effects analyses (FMEAs).
- Ensure nursing practices meet current standards, accreditation requirements, and regulatory expectations (e.g., The Joint Commission, CMS, state boards).
- Collaborate with leaders and frontline staff to implement corrective action plans and sustain compliance.
Health Data Analytics and Reporting
- Partner with data analysts to transform complex data into actionable insights for nurse leaders, providers, and staff.
- Support data-driven decision-making through accurate, timely performance measurement and reporting.
Population Health and Care Coordination
- Integrate population health principles into nursing practice to reduce health disparities and improve outcomes across the continuum.
- Contribute to initiatives that improve patient experience and outcomes across care settings.
Professional Practice Development
- Mentor and educate nurses on quality science, evidence-based practice, and outcomes measurement.
- Assists in developing and revising standards of care and practice to reflect national and regional standards, local practice trends, and current research
- Collaborates with nursing leadership, Legacy Research Institute, Nursing Professional Development Specialists and nursing staff in identifying opportunities for nursing clinical inquiry.
- Maintains currency in clinical practice and knowledge of professional standards of practice through participation in continuing education, community and professional activities, and committee membership.
Education:
- An academic degree in nursing is required (BSN or MSN/MN); master’s degree required.
Experience:
- Four years relevant clinical experience at a proficient to expert level of practice required with demonstrated involvement in quality or performance improvement.
- Preferred: Experience with regulatory/accreditation readiness, patient safety, and data analytics.
Skills:
- Strong knowledge of healthcare quality improvement principles and regulatory standards.
- Ability to work effectively in teams and independently.
- Excellent analytical, project management, organizational and facilitation skills.
- Ability to work in a stressful environment and take appropriate action.
- Excellent verbal and written communication skills including the ability to effectively communicate with staff, patients, and external stakeholders.
- Ability to influence without direct authority and build collaborative partnerships across disciplines.
- Proficiency in data visualization, report generation, and clinical information systems.
- Commitment to continuous learning and professional development in quality and safety science.
- Current applicable state RN license required.
- Certified Professional in Healthcare Quality (CPHQ) (or equivalent) upon hire or intent to obtain within 1 year.
Our Legacy is good for health for Our People, Our Patients, Our Communities, Our World. Above all, we will do the right thing.
If you are passionate about our mission and believe you can contribute to our team, we encourage you to apply—even if you don't meet every qualification listed. We are committed to fostering an inclusive environment where everyone can grow and succeed.
Legacy Health is an equal opportunity employer and prohibits unlawful discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion or creed, citizenship status, sex, sexual orientation, gender identity, pregnancy, age, national origin, disability status, genetic information, veteran status, or any other characteristic protected by law.
To learn more about our employee benefits click here:
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
Able to operate independently in low structure environments, collaborate across business and IT, and deliver high quality, AI ready data ecosystems.
Role Purpose Establish, advance, and mature data quality and governance capabilities in a green field, low maturity data environment.
Support enterprise analytics, BI, and AI/ML readiness through SQL/ETL engineering, data profiling, validation, stewardship, metadata management, and early stage data architecture.
Drive long term improvement of data standards, definitions, lineage, and quality processes.
Key Responsibilities Data Quality & Engineering Perform data audits, profiling, validation, anomaly detection, and quality gap identification.
Develop automated data quality rules and validation logic using T SQL, SQL Server, stored procedures, and indexing strategies.
Build and maintain SSIS packages for validation, cleansing, transformation, and error detection workflows.
Troubleshoot ETL/ELT pipelines, data migrations, integration failures, and data load issues.
Conduct root cause analysis and implement preventive and long term remediation solutions.
Optimize SQL queries, tune stored procedures, and improve data processing performance.
Document audit findings, validation processes, data flows, standards, and quality reports.
Build dashboards and reports for data quality KPIs using Power BI/Tableau.
Data Stewardship & Governance Define, maintain, and enforce data quality standards, business rules, data definitions, and governance policies.
Monitor datasets for completeness, accuracy, timeliness, consistency, and compliance.
Ensure proper and consistent data usage across departments and systems.
Maintain business glossaries, data dictionaries, metadata repositories, and lineage documentation.
Partner with IT, data engineering, and business teams to support governance initiatives and compliance requirements.
Provide training on data entry, data handling, stewardship practices, and data literacy.
Collaborate with cross functional teams to identify recurring data issues and recommend preventive solutions.
GreenField / LowMaturity Environment Architect initial data quality frameworks, validation layers, governance artifacts, and ingestion patterns.
Establish scalable data preparation workflows supporting analytics, BI, and AI/ML readiness.
Mature data quality and governance processes from ad hoc to standardized, automated, and measurable.
Drive adoption of data quality and governance practices across business and technical teams.
Support long term evolution of enterprise data strategy and governance maturity.
Required Technical Skills Advanced T SQL, SQL Server development, debugging, and performance tuning.
SSIS development, deployment, and troubleshooting.
Data profiling, validation rule design, quality scoring, and measurement techniques.
ETL/ELT pipeline design, debugging, and optimization.
Data modeling (conceptual, logical, physical).
Metadata management and lineage documentation.
Reporting and dashboarding with Power BI, Tableau, or similar tools.
Strong documentation and communication skills.
Preferred Skills Knowledge of DAMA DMBoK, DCAM, MDM concepts, and governance frameworks.
Experience in low maturity/green field data environments.
Familiarity with AI/ML data readiness and feature store aligned data structuring.
Cloud data engineering exposure (Azure, Databricks, GCP).
Education Bachelor’s degree in Information Systems, Computer Science, Data Science, Statistics, Business Analytics, or related field.
Master’s degree preferred.
Certifications (Preferred) DAMA CDMP (Associate/Practitioner) EDM Council DCAM ASQ Data Quality Credential Collibra Data Steward Certification Certified Data Steward (eLearningCurve) Cloud/AI certifications (Azure, Databricks, Google)
This role is accountable for rapid, compliant problem resolution across sites while also driving longer-term capability building, standardization, and quality system maturity.
Manage people, projects, and priorities to address resource and operational challenges.
Direct and manage sites during FDA inspections and responses to observations.
Liaison with site operation management providing input and support to ensure Quality and Compliance requirements are being met.
Partners cross-functionally with manufacturing, engineering, regulatory, operations, corporate quality, to increase regulatory compliance.
Support Quality Systems related activities, analyze problems related to quality/regulatory information, and provide process structure and technical support in solving these problems.
Provide expertise, counsel and guidance to Quality leadership.
Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.
Job Description MAJOR RESPONSIBILITIES Lead personnel, activities, and resources for continuous Quality System improvement.
Motivate and engage the team and others around the operational excellence vision and ensure execution.
Advises leadership to ensure the QMS for assigned departments are in compliance as measured by FDA/ISO/internal audits.
Collaborate with cross-functional teams to deploy quality processes and systems.
Consult and provide guidance to business partners.
Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses.
Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses Prepare and deliver Customer presentations Oversee critical Quality systems projects and team that identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business.
Review and determine the application of various system compliance regulations.
Ensure compliance to global regulatory requirements with internal procedures.
Identify risk and compliance opportunities.
Train and coach personnel and cross-functional teams to deliver optimal results.
Management responsibilities include: Typically manages through multiple Managers Provide leadership and management to one or more major departments of an operating unit or to a department that has systemwide accountability Strategic, tactical and operational planning (12 + months) for the function or department Direct budgetary responsibility for one or more departments, functions or major projects/programs Interpret and execute policies for departments/projects; develop, recommend and implement new policies or modifications to existing policies Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in technical or scientific discipline Work Experience Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).
Proficiency in Microsoft Suite.
Position requires travel up to 20% of the time for business purposes (within state and out of state).
Knowledge / Skills / Abilities Job Title: Sr Dir Quality Systems Job Code: 62398 MINIMUM JOB REQUIREMENTS Experience leading people and cross functional teams through quality change and continuous improvement.
Experience hosting FDA/ISO GMP inspections and regulatory meetings.
Experience writing, reviewing, and managing FDA responses Experience with quality systems development and implementation.
Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
Experience in the Medical Device, Pharmaceutical industry, cosmetic, combination product industry.
Experience hosting FDA/ISO GMP inspections.
Proficiency in analyzing and reporting data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
Demonstrated ability to control and coordinate team priorities, concurrent projects, competing priorities and critical deadlines.
Position requires travel up to 25% of the time for business purposes (within state, out of state and/or internationally).
PREFERRED JOB REQUIREMENTS Work Experience 8 years or more of managerial experience preferred.
10 years or more of related experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products industries preferred.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position: $203,000.00
- $305,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
This role is bonus and/or incentive eligible.
Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
For a more comprehensive list of our benefits please click here .
For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.
Explore our Belonging page here .
Medline Industries, LP is an equal opportunity employer.
Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.