Principal Supplier Quality Engineer

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

Work location: Trumbull CT or Livingston NJ (hybrid)

Scope:

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.

Job Summary:

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 organizations 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.

Technical Leadership & Engineering Excellence

• 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.

Supplier Quality Engineering

• 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.

Validation & Process Controls

• 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

Corrective Action & Quality Improvement

• 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

Strategic Business Partnership

• 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.

Travel:This position may require 20-35% domestic and/or international travel.

Knowledge Skills and Abilities:

• 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.

Experience:

• 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.

Work Environment:

• Manufacturing laboratory warehouse clean room supplier and office environments.

• May require extended periods of sitting standing and movement in production and supplier facilities.

Education:

• Bachelors Degree in Engineering Materials Science Mechanical Engineering Biomedical Engineering Chemical Engineering or related technical field required.

• Masters Degree preferred.

• ASQ (CQE/CQA) Six Sigma Black Belt preferred.

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Our Benefits:

As an employee of CooperSurgical youll 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 atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

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 payfor this role is between$120000.00 - $160000.00 annually. Theactual base payincludes 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.