Senior Supplier Quality Engineer - Risk & Compliance Leader

CooperSurgical; Livingston (NJ); On-site; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Job summary

CooperSurgical, a leading fertility and women’s health company, seeks a Senior Supplier Quality Engineer to lead global supplier quality activities. You will own audits, risk management, SCARs, and continuous improvement, collaborating with procurement, engineering, and regulatory to ensure QMS compliance and product quality across critical suppliers.

This role involves travel and mentoring junior engineers, with responsibilities spanning supplier development, NPI support, and change management

Qualifications

• Bachelor’s degree in a Life Science, Engineering, or related field.
• 7+ years in a regulated quality environment (medical devices/pharma).
• Experience leading supplier audits, SCARs, and supplier development.
• Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.

Responsibilities

• 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 and complex supply chain issues.
• Provide guidance to Supplier Quality Engineers and cross‑functional stakeholders.
• Plan, perform, and lead supplier audits (on‑site, remote, desktop).
• Own and drive Supplier Corrective Action Requests (SCARs) and NCMRs.

Skills

Supplier quality management

Regulatory compliance

Cross-functional leadership

Root cause analysis

Audits and inspections

Risk management

Quality systems

Communication

Problem solving

Education

Bachelor’s Degree in Life Science/Engineering

Tools

MS Office

Minitab

ERP systems

eQMS

Job description

CooperSurgical, a leading fertility and women’s health company, seeks a Senior Supplier Quality Engineer to lead global supplier quality activities. You will own audits, risk management, SCARs, and continuous improvement, collaborating with procurement, engineering, and regulatory to ensure QMS compliance and product quality across critical suppliers.

This role involves travel and mentoring junior engineers, with responsibilities spanning supplier development, NPI support, and change management