New · posted Oct 15
The Cooper Companies · Medical Devices
Senior Supplier Quality Engineer
- Trumbull, CT +1 more
- Hybrid
- Full-time
- Senior & Principal
Open until filled
The role
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 high‑impact supplier changes, and plays a key role in management review, audit readiness, and continuous improvement initiatives.
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 cross‑functional teams.
Supplier Quality Leadership
- Lead end‑to‑end supplier quality activities for assigned suppliers, including onboarding, qualification, monitoring, re‑evaluation, 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 cross‑functional stakeholders.
Supplier Audits & Compliance
- Plan, perform, and lead supplier audits (on‑site, remote, desktop) in accordance with internal procedures and regulatory expectations.
- Ensure audit findings, risk assessments, and follow‑up actions are effectively managed and closed.
- Serve as a key contributor during regulatory inspections and notified body audits, supporting back‑room activities and supplier-related inquiries.
Supplier Performance & Risk Management
- 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.
Corrective Actions & Change Management
- Own and drive Supplier Corrective Action Requests (SCARs), ensuring robust root cause analysis, effective corrective actions, and sustained improvement.
- Lead supplier‑related 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.
Quality Systems & Documentation
- 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.
What you need
Education
Bachelor’s 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.
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 cross‑functional teams and influence without authority.
Advanced problem‑solving 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.
Pay
$100,000 – $125,000 a year
Employer providedFor U.S. locations that require disclosure of compensation, the starting base pay for this role is between $100,000.00 - $125,000.00 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.
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.
Where you'll work
Trumbull, CT +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Livingston, NJ (Hybrid)
More jobs in Trumbull, CT +1 moreWorking conditions
Manufacturing, clean room, warehouse, and office environments.
May require extended periods of sitting, standing, and movement in production and supplier facilities.
Travel: This position may require 15-30% domestic and/or international travel.
From the posting
About The Cooper Companies
About CooperSurgical
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.
Equal opportunity, accessibility and legal noticesThe Cooper Companies's statements, word for word
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 place. 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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 8% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in Connecticut12 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $100,000 | — | $125,000 |
| Connecticut (middle half) | $99,000 | $117,750 | $134,000 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: The Cooper Companies's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not The Cooper Companies's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk26
- Collaboration and leadership12
- GMP and compliance9
- Documentation and SOPs4
- Investigations and CAPA4
- Validation and qualification3
- Lab testing and methods1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
Company hiring pulse
The Cooper Companies on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 5
- Locations
By discipline
- Quality9 90%
- Regulatory1 10%
By level
- Senior & Principal8 80%
- VP & Executive1 10%
- Manager1 10%
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Senior Supplier Quality Engineer at The Cooper Companies
Open until filled. $100K–$125K a year, employer provided.