Global Supplier Quality Lead

CooperSurgical; Trumbull (CT); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical in Trumbull, CT or Livingston, NJ, seeks a Supplier Quality Engineer Lead to govern supplier qualification, audits, and escalation for high‑risk suppliers, partnering with Procurement, Operations, and Regulatory.

This role drives continuous improvement, leads governance across the supplier lifecycle, and mentors engineers, with travel 15‑30% domestically or internationally.

Qualifications

• Expert knowledge of FDA QSR (21 CFR 820), ISO 13485, EU MDR, ISO 14971.
• Strong leadership in supplier quality governance, audits, CAPA/SCAR, and risk management.
• Ability to lead through influence and manage complex cross‑functional initiatives.
• Advanced problem‑solving and quality tool expertise (RCA, FMEA, statistical analysis).

Responsibilities

• Define and lead supplier quality strategy aligned with regulatory requirements.
• Provide mentoring to Supplier Quality Engineers.
• Lead global supplier audits programs (onsite, remote, desktop).
• Act as primary Quality representative for supplier regulatory interactions and inspections.

Skills

Leadership in supplier quality

Cross-functional collaboration

Problem solving (RCA, FMEA)

Executive communication

MS Office, Minitab, ERP, eQMS

Education

Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Biomedical, Bioprocess Engineering or Life Science

CQE, ASQ, APICS, Six Sigma Green Belt/Black Belt preferred

Tools

MS Office

Minitab

ERP systems

eQMS platforms

Job description

CooperSurgical in Trumbull, CT or Livingston, NJ, seeks a Supplier Quality Engineer Lead to govern supplier qualification, audits, and escalation for high‑risk suppliers, partnering with Procurement, Operations, and Regulatory.

This role drives continuous improvement, leads governance across the supplier lifecycle, and mentors engineers, with travel 15‑30% domestically or internationally.