Principal Supplier Quality Engineer
CooperSurgical
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Job summary
CooperSurgical seeks a Principal Supplier Quality Engineer to drive supplier quality systems, process validation, and risk management across global networks. You’ll serve as a technical expert, guiding design transfer, manufacturing controls, and regulatory inspections while mentoring engineers and collaborating with R&D, Operations, and Regulatory Affairs.
Expect 20-35% travel and a focus on continuous improvement.
Qualifications
- Bachelor's degree in Engineering or related field required.
- Master's degree preferred.
- ASQ CQE/CQA certification is desirable.
Responsibilities
- Provide strategic leadership for supplier quality systems and risk management.
- Lead validation strategies and supplier quality improvement initiatives.
- Collaborate with cross-functional teams and regulatory affairs.
- Support regulatory inspections and supplier transfers.
Skills
Education
Tools
Job description
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com .
CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com .
Trumbull, CT or Livingston, NJ (hybrid)
The Principal Supplier Quality Engineer serves as the highest-level technical authority within Supplier Quality Engineering and provides enterprise-wide leadership for supplier quality strategy, technical risk management, product realization, and supplier compliance activities. This role is responsible for establishing technical standards, leading complex quality initiatives, and providing expert guidance on supplier-related product, process, and compliance decisions. The Principal Supplier Quality Engineer drives quality excellence across the product lifecycle and partners with Engineering, Operations, Procurement, Regulatory Affairs, R&D, Manufacturing, and business leadership to ensure supplier processes and product quality meet regulatory, customer, and business requirements. The role operates with significant autonomy and serves as a recognized subject matter expert for critical supplier quality and engineering challenges.
The Principal Supplier Quality Engineer provides strategic technical leadership for supplier quality systems, process validation, risk management, auditing, supplier development, product realization and external manufacturing operational oversight activities. This role leads to the resolution of highly complex quality and engineering issues impacting product safety, efficacy, reliability, compliance, and supply continuity. The position serves as the organization's technical expert for supplier-related quality engineering matters, including design transfer, process validation, manufacturing controls, risk management, supplier change management, and regulatory inspection support. The Principal Supplier Quality Engineer influences business strategy through technical expertise and drives continuous improvement across global supplier networks.
- Serve as the technical authority for supplier quality engineering across the organization.
- Establish engineering standards, best practices, and technical governance frameworks for supplier controls.
- Lead resolution of complex supplier quality, manufacturing, and compliance issues requiring advanced technical expertise.
- Provide technical guidance and mentorship to Supplier Quality Engineers, and cross-functional teams.
- Review and approve technical assessments impacting critical suppliers, products, and manufacturing processes.
- Influence senior leadership decisions related to supplier risk, sourcing strategy, and business continuity.
- Lead technical evaluation, qualification, and ongoing oversight of critical and strategic suppliers.
- Establish supplier quality engineering requirements related to process capability, validation, inspection methods, and quality controls.
- Drive supplier process improvement initiatives using statistical and engineering methodologies.
- Lead technical supplier development programs to improve quality, reliability, manufacturability, and capability.
- Support supplier selection and sourcing decisions through technical risk assessments.
- Ensure effective integration of supplier quality requirements into product development and commercialization programs.
- Evaluate technical impacts associated with Supplier Change Notifications (SCNs), deviations, concessions, and process changes.
- Support and lead supplier related risk assessment and support supplier transfers, and manufacturing readiness activities.
- Provide supplier quality oversight of supplier validation programs, including IQ/OQ/PQ, process validation, software validation, and special process qualification.
- Support establishment requirements for process capability studies, measurement system analysis, and statistical controls.
- Review and approve validation strategies and technical documentation for critical supplier processes
- Lead investigation and resolution of significant supplier-related quality events.
- Provide technical oversight for SCARs, CAPAs, NCMRs, and complex root cause investigations.
- Utilize advanced problem-solving methodologies to address recurring and systemic quality issues.
- Monitor quality trends and drive enterprise-wide preventive improvement initiatives
- Influence supplier quality strategy through technical expertise.
- Partner with Executive Leadership, R&D, Operations, Procurement, and Regulatory Affairs on strategic quality initiatives.
- Present technical recommendations, risk evaluations, and quality performance metrics to senior leadership.
- Support business continuity planning and supplier resiliency initiatives.
This position may require 20-35% domestic and/or international travel.
- Expert knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, ISO 14971, and applicable supplier quality regulations.
- Advanced expertise in quality engineering, process validation, statistical methods, risk management, and supplier quality systems.
- Demonstrated ability to influence decisions across organizational and executive leadership levels.
- Strong understanding of manufacturing processes, materials, special processes, and inspection technologies.
- Excellent presentation, communication, and technical writing skills.
- Proficiency with Minitab, statistical software packages, ERP systems, PLM systems, and electronic QMS platforms.
- 12+ years experience in a regulated quality environment (medical device, pharma, life sciences).
- 10+ years experience in Supplier/Vendor Quality Management (direct or relevant experience).
- Demonstrated technical leadership of complex supplier quality initiatives and cross-functional programs.
- Experience supporting global regulatory inspections and supplier networks.
- Proven record of driving technical improvements that improve product quality, compliance, and operational performance.
- Manufacturing, laboratory, warehouse, clean room, supplier, and office environments.
- May require extended periods of sitting, standing, and movement in production and supplier facilities.
- Bachelor’s Degree in Engineering, Materials Science, Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related technical field required.
- Master's Degree preferred.
- ASQ (CQE/CQA), Six Sigma Black Belt preferred.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $120,000.00 - $160,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
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