Senior 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 (on-site)

Scope:

The Senior Supplier Quality Engineer is responsible for leading and driving all aspects of the Global Supplier Quality Management Program. This role ensures supplier compliance with regulatory requirements corporate quality standards and business expectations while proactively improving supplier performance risk management and product quality.

This position serves as a subject matter expert (SME) for supplier quality and works independently with minimal supervision while mentoring junior engineers and influencing crossfunctional teams.

Job Summary:

The Senior Supplier Quality Engineer leads supplier qualification monitoring auditing development and corrective action activities for critical and strategic suppliers. This role has ownership of complex supplier quality issues including Risk 1 suppliers outsourced processes and highimpact supplier changes and plays a key role in management review audit readiness and continuous improvement initiatives.

Supplier Quality Leadership

• Lead endtoend supplier quality activities for assigned suppliers including onboarding qualification monitoring reevaluation and disqualification.
• Act as Supplier Quality SME for critical suppliers outsourced processes and complex supply chain issues.
• Provide guidance and mentorship to Supplier Quality Engineers and crossfunctional stakeholders.
• Plan perform and lead supplier audits (onsite remote desktop) in accordance with internal procedures and regulatory expectations.
• Ensure audit findings risk assessments and followup actions are effectively managed and closed.
• Serve as a key contributor during regulatory inspections and notified body audits supporting backroom activities and supplier-related inquiries.
• Lead supplier risk classification risk assessments and mitigation planning.
• Drive supplier performance monitoring using metrics trend analysis Pareto analysis and risk review tools.
• Present supplier performance metrics and risk assessments to Management Review and senior leadership.

Supplier Audits & Compliance

Supplier Performance & Risk Management

Corrective Actions & Change Management

• Own and drive Supplier Corrective Action Requests (SCARs) ensuring robust root cause analysis effective corrective actions and sustained improvement.
• Lead supplierrelated Nonconforming Material Reports (NCMRs) and support escalation management when required.
• Evaluate and support Supplier Change Notifications (SCNs) and change impact assessments.

Supplier Development & Continuous Improvement

• Lead supplier development initiatives to improve quality delivery compliance and business continuity.
• Support new product introduction (NPI) supplier transfers localization projects and business continuity initiatives.
• Support and influence IQ OQ PQ PPAP validation and qualification activities from a supplier quality perspective.
• Develop maintain and improve Supplier Quality Agreements and supplier management SOPs forms and workflows.
• Ensure supplier records and documentation are complete accurate and compliant with QMS and regulatory requirements.
• Collaborate with Procurement Engineering Operations and Regulatory teams to ensure supplier alignment across the product lifecycle.

Quality Systems & Documentation

Travel: This position may require 15-30% domestic and/or international travel.

Knowledge Skills and Abilities:

• Expert knowledge of FDA QSR (21 CFR 820) ISO 13485 EU MDR ISO 14971.

• Strong experience with supplier risk management audits SCAR/CAPA and performance monitoring.

• Proven ability to lead crossfunctional teams and influence without authority.

• Advanced problemsolving skills using quality tools (e.g. root cause analysis FMEA statistical methods).

• Strong written and verbal communication skills including interaction with senior leadership and external suppliers.

• Proficient in MS Office Minitab and experience with ERP and eQMS systems.

Experience:

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

• 5 years direct experience in Supplier Quality Management.

• Demonstrated experience leading supplier audits complex SCARs supplier development and compliance initiatives.

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 Chemical Electro-Mechanical Industrial Biomedical Bioprocess Engineering or related to Life Science field or equivalent experience or skillset.

• CQE ASQ APICS Six Sigma Green Belt / 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$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.