Quality Engineering, CO Jobs in Usa

Job Summary

Shift: Every Other Wednesday and Every Thursday, Friday & Saturday 6am-6pm

• Develop, implement, and maintain quality control plans and procedures for new and existing products.

• Conduct root cause analysis for product non-conformances and process deviations, implementing effective corrective and preventive actions (CAPA).

• Perform statistical analysis of quality data to identify trends, opportunities for improvement, and risks.

• Participate in design reviews, process validations, and manufacturing readiness reviews to ensure quality requirements are met.

• Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Supply Chain) to integrate quality into product development and production.

• Support internal and external audits, ensuring compliance with ISO standards, customer specifications, and regulatory requirements.

• Develop and deliver quality training to manufacturing personnel and other stakeholders.

• Review and approve engineering changes, ensuring their impact on product quality is assessed and controlled.

• Drive continuous improvement initiatives using methodologies such as Six Sigma, Lean Manufacturing, and FMEA.

• Document and report on key quality metrics and performance indicators.

Job Qualifications

• Bachelor's degree in Engineering (e.g., Mechanical, Electrical, Industrial, Manufacturing) or a related technical field.

• 3-5 years of experience in a Quality Engineering role within a manufacturing environment.

• Strong understanding of quality management systems (e.g., ISO 9001, AS9100, ISO 13485 depending on industry).

• Proficiency in statistical process control (SPC), measurement system analysis (MSA), and other quality tools.

• Demonstrated experience with root cause analysis methodologies (e.g., 8D, 5 Why, Fishbone diagrams).

• Excellent analytical, problem-solving, and decision-making skills.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse teams.

• Ability to read and interpret technical drawings and specifications.

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• ASQ certifications (e.g., CQE, CSSBB) are a plus.

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• 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.
  

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

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• 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.
  

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• 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
  

Title: Engineering Technician

Location: Orangeburg, SC 29115

Hire Type: Contract to Hire

Salary: $23- $27/hr

Benefits: Paid time off, 401K, health/dental/vision options, opportunities for overtime

We are seeking an experienced Assembly Team Lead to join our production team. This is a hands-on leadership role where you will guide a team, optimize assembly processes, and ensure high-quality output. This is an exciting opportunity for someone who enjoys mentoring, process improvement, and working in a fast-paced manufacturing environment.

Job Duties:

• Develop, maintain, and improve assembly processes to reduce inefficiencies and increase productivity.
• Collaborate with Quality Engineers to monitor tools, identify root causes, and implement corrective actions.
• Drive production schedules while resolving process-related challenges.
• Support Engineering and Development Labs with new product introductions and process validation.
• Ensure compliance with safety regulations, ISO standards, and company controls.
• Provide accurate production documentation, including MPIs, equipment setup, and programs.
• Troubleshoot minor machine issues, perform adjustments, and assist in maintenance under supervision.
• Monitor equipment performance and suggest improvements for setup, calibration, or alignment.
• Assist operators by answering questions, demonstrating proper techniques, and ensuring quality standards.
• Conduct spot checks to maintain consistent product quality.
• Stay up-to-date with manufacturing support, process changes, and equipment upgrades.

Qualifications:

• Proven experience in assembly operations with prior leadership responsibilities.
• Strong problem-solving abilities and process improvement mindset.
• Knowledge of safety standards, ISO requirements, and production documentation.
• Hands-on experience with equipment setup, troubleshooting, and minor maintenance.
• Excellent communication, coaching, and collaboration skills.
• Detail-oriented and committed to maintaining high-quality standards.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day-to-day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests.

Responsibilities:

• Provide ongoing quality engineering support throughout the product life cycle.
• Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
• Support process risk management activities and ensure quality and completeness of validation packages, and change orders.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Review verification and validation reports and identify gaps for GMP compliance.
• Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
• Collaborate with counterparts and cross-functional teams at other sites.
• Other activities as assigned.

Education:

• Bachelor’s degree in an engineering discipline.

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.

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

Ready to shape the future of work?

At Genpact, we don’t just adapt to change—we drive it. AI and digital innovation are redefining industries, and we’re leading the charge. Genpact’s AI Gigafactory, our industry-first accelerator, is an example of how we’re scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies’ most complex challenges.

If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that’s shaping the future, this is your moment.

Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implementdata, technology, and AI to create tomorrow, today. Get to know us at and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Manufacturing Project Lead / Quality Engineer

Job title: Manufacturing Project Lead / Quality Engineer

Location: Cincinnati, OH (On-Site)

Type of Hire: Full-time

Job Description

In this role, you will engage with quality engineering teams and support in validating various non-conformance reports. You will be responsible to coordinate with different teams to drive solutions for key customer issues.

Responsibilities

• Review submitted non-conformances and validated actual non-conformances with Metrology lab, participate in required conference calls and meetings.
• Technical expertise to interpret aerospace drawings / blueprints.
• Track and route eNMS tickets as required.
• Complete change management documentation as required.
• Perform First Article Inspections in accordance with AS9102 standards.
• Knowledge on Production Part Approval Process (PPAP).
• Perform visual and dimensional inspections on fully assembled and sub-assembly parts to ensure conformity and on time delivery.
• Skilled in applying GD&T principles to ensure product quality and functionality
• Conduct internal audits in accordance with ISO 9001 and AS9100 requirements
• Audit production workers to ensure NADCAP guidelines are being met, as well as adhering to quality planning.
• Provide weekly performance reports detailing identified KPIs. (completed/open MRB tickets).
• Provide time and expense reports.
• Provide weekly summary of facts/observations/progress of project.

Qualifications we seek in you!

Minimum Qualifications

• Bachelor’s degree in engineering/business from an accredited university or college.
• At least 3-4 years of experience in Aviation / Engineering.
• Prior experience with metrology, blueprints interpretation, Geometric dimensioning and tolerancing (GD&T) measurement techniques.
• Strong quantitative and analytical skills.
• Strong oral, written communication skills, excellent customer relationship building skills, strong interpersonal and leadership skills.

Preferred Qualifications/ Skills

• Strong Business Acumen, and Analytical capability.
• AS9100D Internal Auditing Certification
• Knowledge on PFMEA
• Strong blueprint reading skills, high level knowledge of GD&T SAE 13001 Certified.
• Demonstrated ability to lead, mentor and influence customer and peers.
• Demonstrated capability to multitask in a fast-paced environment.
• Experience with Lean and Six Sigma / Process Improvement activities.

Why join Genpact?

• Be a transformation leader – Work at the cutting edge of AI, automation, and digital innovation

• Make an impact – Drive change for global enterprises and solve business challenges that matter

• Accelerate your career – Get hands-on experience, mentorship, and continuous learning opportunities

• Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day

• Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.

Let’s build tomorrow together.

The approximate annual base compensation range for this position is [$70,000 to $77,000]. The actual offer, reflecting the total compensation package plus benefits, will be determined by a number of factors which include but are not limited to the applicant’s experience, knowledge, skills, and abilities; geographic location; and internal equity

“Los Angeles, California based candidates are not eligible for this role. Cincinnati, OH area candidates are eligible for this role only.”

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

How Will You Make an Impact?

As a Quality Engineer at our Auburn Hills, MI facility , you will ensure the highest quality standards are upheld throughout the full product lifecycle—from initial design through manufacturing and final delivery. You will develop and maintain quality systems, drive continuous improvement initiatives, resolve product and process issues, and maintain compliance with industry regulations and customer requirements. Your work will directly influence product reliability, customer satisfaction, and operational excellence across the site.

On-site at our Auburn Hills, MI facility, with occasional travel to suppliers or other Jabil sites as required.

• Design, develop, and implement quality control plans, inspection procedures, and testing methods for new and existing products.
• Lead root cause investigations and drive effective corrective and preventive actions (CAPA).
• Partner with suppliers to establish and maintain quality standards, conduct supplier audits, and monitor supplier performance.
• Utilize statistical process control (SPC) tools to monitor processes, identify trends, and recommend improvements to reduce defects.
• Ensure compliance with ISO 9001, AS9100, IATF 16949, customer requirements, and internal quality management systems.
• Maintain accurate and comprehensive quality documentation.
• Drive and support continuous improvement efforts using Lean, Six Sigma, Kaizen, 8D, and other methodologies.
• Act as a primary interface for customer quality inquiries; resolve customer complaints and communicate quality performance updates.
• Provide quality training, guidance, and mentorship to manufacturing teams and cross‑functional groups.
• Compile and analyze quality data; generate reports and present findings to leadership for decision‑making.
• Perform other duties as assigned.

Education

• Bachelor’s degree in Engineering (Mechanical, Electrical, Industrial, Manufacturing, or related field) required.

Experience

• 3–5 years of experience in a Quality Engineering role within manufacturing.
• Experience in electronics, medical devices, automotive, or aerospace preferred.
• Equivalent combinations of education and experience may be considered.

Knowledge, Skills & Abilities

• Strong understanding of quality management systems such as ISO 9001, AS9100, and IATF 16949.
• Proficiency with SPC, Minitab, FMEA, control plans, and PPAP processes.
• Demonstrated experience using 8D, 5 Whys, and Fishbone methodologies for problem-solving.
• Excellent written and verbal communication skills across all organizational levels.
• Strong analytical skills, attention to detail, and ability to manage multiple priorities.
• Proficient in Microsoft Office Suite; experience with ERP systems is a plus.

Preferred Qualifications

• ASQ certifications such as CQE, CSSBB, or CMQ/OE.
• Experience with supplier quality management, supplier audits, and quality improvement initiatives.
• Lean or Six Sigma experience.

Associate Director, Quality Management

Manufacturing | Quality Leadership

Location: Platte County, Nebraska

A regulated, global manufacturing organization is seeking an Associate Director, Quality Management to lead site-wide quality strategy and drive cultural transformation at a large, complex operation.

This is a senior leadership role with high visibility, influence, and long-term growth potential for a quality leader who thrives in change-oriented environments.

What You’ll Do

• Serve as the site Quality Leader overseeing Quality Assurance, Quality Control, Quality Systems & Compliance, and Quality Engineering
• Act as the management representative for regulatory bodies, notified bodies, and customers
• Lead GMP-compliant quality systems, including CAPA, audits, validation, change control, document control, and complaint management
• Drive quality transformation and continuous improvement in partnership with Manufacturing, Engineering, and Supply Chain
• Build, coach, and develop a high-performing quality organization
• Champion a culture of quality excellence, accountability, and urgency
• Play a key role on the site leadership team while aligning with global quality strategy

What They’re Looking For – “Must haves”

• Bachelor’s degree in a technical or scientific field (advanced degree preferred)
• 10+ years of medical device/ pharma manufacturing environment experience
• 10+ years of plant-level Quality leadership experience
• Previous experience leading Manufacturing Ops/ OpEx teams is critical
• Strong working knowledge of 21 CFR 820, 210/211, ISO 9001, and ISO 13485
• Proven ability to lead change and elevate a quality culture
• Experience interfacing with customers and regulatory agencies
• Continuous Improvement mindset with the ability to influence at all levels

Why This Role

• Critical leadership position at a flagship manufacturing site
• Opportunity to drive real, structural change rather than maintain the status quo
• Clear runway for future advancement within a global organization
• Competitive compensation, including LTI, benefits, and relocation support for the right candidate

Candidates holding visas are not being considered for this role.

Global Product Quality Specialist

12-month Contract

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.

Hiring: Production Quality Inspector

Manchester, CT | Aerospace Manufacturing

The aerospace industry is at a turning point, and our client is breaking the mold. They are a next-generation manufacturer combining startup speed with deep industry expertise, using automation, AI-driven tools, and a fully connected digital backbone to reinvent how flight-critical components are built and scaled.

They're looking for a Production Quality Inspector to ensure that quality isn't just a checkpoint, but something built into every part they ship.

What You’ll Do

• Full-Lifecycle Inspection: Own visual, dimensional, and physical inspections across the production journey—including in-process, first-piece, and final.
• Blueprint & Technical Validation: Interpret complex engineering drawings and GD&T specifications to ensure every part meets tight design tolerances.
• AS9102 First Articles: Lead and document First Article Inspections (FAI) to validate that initial production runs meet all customer and regulatory specs.
• Advanced Measurement: Utilize a high-precision toolkit including CMMs, borescopes, micrometers, height gauges, and calipers.
• Documentation & NCRs: Maintain impeccable traceability records (Logs, CoCs) and partner with Quality Engineering to identify and resolve nonconformances (NCRs).
• Audit Support: Support internal and external QMS audits for compliance with AS9100 and regulatory standards.

What You’ll Bring

• 3+ years of Quality Inspection experience specifically within an aerospace manufacturing environment.
• Technical Expertise: Strong proficiency in GD&T and expertise in reading/interpreting aerospace blueprints.
• Compliance Knowledge: Deep familiarity with AS9100 standards and FAA regulations; an active A&P License or Repairman Certificate is preferred.
• Software Fluency: Experience with ERP systems (SAP, Epicor) and/or CATIA/CAD tools.
• Precision Focus: Ability to pass visual acuity/color discrimination exams and thrive in a fast-paced factory setting.

Role Details

• Growth: Work alongside elite innovators to shape the future of autonomous and scalable aviation.
• Package: Competitive hourly rate, Full Benefits (Medical, Dental, Vision, 401k).

Hydraulic Design Engineer

Location: Raleigh, NC

Salary: Commensurate with experience + Benefits

About the Role

Wetherill Engineering, Inc. (WEI) is seeking a Hydraulic Design Engineer to support transportation and roadway drainage projects. This role involves hydrologic and hydraulic analysis, stormwater system design, and collaborating with multidisciplinary teams to deliver high-quality solutions.

Key Responsibilities

• Design and analyze roadway drainage, stormwater management, and erosion control systems.
• Perform hydrology and hydraulic analysis for transportation projects.
• Develop plans for stormwater management systems, bridge and culvert hydraulics, and BMPs.
• Utilize MicroStation, GEOPAK Drainage, HEC-RAS, Open Roads Designer, and SUDA.
• Assist in fieldwork to verify site conditions.
• Support project coordination and provide technical direction.

What You Bring

• B.S. or M.S. in Civil Engineering (or related field).
• P.E. license preferred (or ability to obtain).
• 5+ years of transportation hydraulic design experience (NCDOT projects preferred).
• Proficiency in MicroStation, Microsoft Office, and Adobe Acrobat.
• Strong understanding of NCDOT Guidelines, FHWA Hydraulic Design Manual, and erosion control.
• Excellent communication, teamwork, and problem-solving skills.
• Experience or willingness to manage projects is a plus.

Why WEI?

• Competitive salary + health, dental, vision, life, and retirement benefits.
• ESOP, SPSF, HUB-certified firm.
• Ranked among Top MWBE Firms and Top 74 Southeast Engineering Firms (ENR).
• Supportive and collaborative work environment with growth opportunities.

Equal Opportunity Employer | No sponsorship available.

Apply on LinkedIn, at , or email for more information.

This description is not a comprehensive listing of activities, duties, or responsibilities that may be required of the employee and other duties, responsibilities, and activities may be assigned or may be changed at any time with or without notice.

SUMMARY
To assist the Quality Assurance function as technical support in issues affecting manufacturing. To support and drive corrective action efforts.

Kelly® Science & Clinical is seeking a Process Engineering Manager for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Workplace: Onsite in Colorado Springs, CO

Position Title: Process Engineering Manager, Oral Dosage Forms

Position Type: Direct hire

Salary: $125,000-140,000

Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.

Responsibilities

Strategic Process Development & Scale-Up

• Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
• Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
• Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution

Technology Transfer Leadership

• Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
• Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
• Lead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practices

Pilot Plant & cGMP Operations Management

• Oversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
• Drive continuous improvement projects—maximizing efficiency, quality, and yield
• Provide expert troubleshooting and manage deviations, ensuring on-time project delivery

Capital Projects & Facility Optimization

• Lead equipment qualification and validation for cutting-edge process installations
• Direct facility expansion and modification projects to support innovation and new technology implementation
• Optimize facility workflows to enhance operational excellence and scalability

Quality Assurance & Regulatory Compliance

• Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
• Develop and execute robust process validation strategies in accordance with global regulatory standards
• Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness

Project Management & Client Engagement

• Manage multiple, high-profile client technology transfer programs—delivering on time and within budget
• Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
• Develop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activities
• Mentor cross-functional teams, fostering a culture of excellence and innovation

Qualifications

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred

Experience:

• 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environment
• Demonstrated success managing complex, cross-functional projects in a regulated setting

Technical Mastery

• Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
• Comprehensive understanding of cGMP, quality systems, and regulatory compliance
• Proven skills in process automation, risk management, and project execution

Leadership & Collaboration

• Recognized leadership in guiding technical teams and cross-functional project groups
• Outstanding client relationship management and communication abilities
• Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams

Why Join Us?

• Work alongside industry leaders and innovators
• Participate in high-impact projects accelerating life-saving therapies to market
• Competitive salary, comprehensive benefits, and opportunities for continued professional growth

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.