Senior Supplier Quality Engineer- External Manufacturing

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 Senior Supplier Quality Engineer (External Manufacturing) is responsible for providing quality oversight of external manufacturing and supplier quality.

Job Summary:

The Senior Supplier Quality Engineer (External Manufacturing)is responsible for managing the external and contract manufacturing ensuring that products manufactured by thirdparty suppliers meet Cooper Surgicals quality regulatory and performance standards. This role acts as the primary technical interface between CooperSurgical and its external suppliers driving quality systems leading issue resolution and supporting continuous improvement across the supply base. Plays a critical role in supplier qualification ongoing performance management process validation and ensuring compliance with internal standards and external regulations.

• Oversee the management of external manufacturing suppliers fordevelopment and execution of plans/strategies and implementation of systems processes and procedures to ensure robust supplier/purchasingcontrols with regards to the determinationselection qualification monitoring and disengagement of suppliers.
• Lead routine operational quality reviews with external manufacturing partners to ensure ongoing compliance with quality system requirements product specifications and key operational metrics.
• Provide day-to-day quality oversight of contract manufacturing operations including batch record review production monitoring nonconformance management and escalation of quality issues.
• Review and trend quality data from external manufacturing sites including deviations scrap yield complaints rework and CAPA effectiveness identifying opportunities for risk reduction and continuous improvement.
• Approve suppliers based on risk performance history and alignment with business needs.
• Lead PPAP/FAI reviews and ensure successful qualification of new products or components.
• Proactively identify develop and lead the investigation and resolution of supplier-related challenges and implement appropriate Quality Engineering methodologiesinsupport of supplier-related changes risk management to improve supplier reliability minimize risks and ensure sustainable material supply.
• Provide SQ support topurchasingcontrol audits of our external manufacturing sites. Maintain supplier quality documentation audit reports and qualification packages.
• Participate in Material Review Board (MRB) activities and support containment rework and disposition decisions and defect prevention activities for nonconforming products and materials manufactured by external partners.
• Review and approve process validation protocols (IQ/OQ/PQ).
• Ensure adherence to control plans PFMEA and SOPs.
• Support engineering changes product transfers tooling validation and rampups. Ensure change control processes are followed for materials processes and equipment.
• Ensure all external manufacturing activities comply with industry regulations and organizational policies.
• Support quality management reviews audits timely investigation of deviations CAPAs and product disposition.
• Support NPI products to align with R&D timelines quality standards and operational limitations.
• Perform on-site quality oversight visits at contract manufacturing facilities to verify compliance process adherence operational controls and execution of corrective actions

Performance Monitoring

• Monitor manufacturing performance using Operational Excellence (OPEX) metrics as appropriate; provide regular updates to supply chain leadership
• Ensure timely communication with third-party manufacturers regarding product forecasts manufacturing and delivery schedules.
• Ensure adherence to terms in the Supply Agreement and Quality Agreement.
• Provide regular updates and reports to the supply chain leadership.
• Monitor and report supplier quality performance (PPM defect trends NCRs OEE delivery Complaint rates SCAR closure effectiveness).
• Lead monthly/quarterly business reviews with key suppliers.
• Develop and execute supplier improvement plans.
• Manage scorecards and continuous improvement expectations.
• Work as a liaison between the suppliers andCooper Surgical team.

Travel:

This position may require up to 30% domestic and/or international travel.

Knowledge Skills and Abilities:

• Strong understanding of manufacturing processes (injection molding machining assembly packaging electronics finished good manufacturing etc. depending on industry).

• Proficiency with quality tools: APQP PPAP FMEA SPC MSA AQL.

• Ability to analyze data and interpret statistical trends.

• Experience with global manufacturing and supplier management.

• Familiarity with international regulatory requirements and market trends

• Strong communication and negotiation with external suppliers.

• Ability to influence without authority.

• Crossfunctional leadership and project management skills.

Experience:

• 5 years in supplier quality external manufacturing or process engineering or relevant experience.

• 7 years in a regulated quality environment (medical device pharma life sciences).

• Experience working with global suppliers and contract manufacturers preferred.

Work Environment:

• Manufacturing clean room warehouse and office environments.

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

Education:

• Bachelors degree in engineering (Mechanical Industrial Manufacturing Chemical or equivalent) or equivalent experience or skillset.

• Certifications (Lead Auditor ASQ CQE Six Sigma Green/Black Belt) preferred.

#LI-KA1

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$100000.00 - $125000.00 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.