Global Supplier Quality Lead (Hybrid, 15-30% Travel)

Regulatory Toolkit; Trumbull (CT); Hybrid; USD 100,000 - 125,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Senior Supplier Quality Engineer to lead supplier qualification, audits, CAPAs, and risk management across critical suppliers. You will mentor junior engineers and partner with regulatory, engineering, and procurement teams to ensure product quality and compliance.

The role requires 7+ years in a regulated quality environment and 5+ years in supplier quality, with expertise in FDA QSR, ISO 13485, EU MDR, and ISO 14971.

Qualifications

• 7+ years in a regulated quality environment (medical device, pharma, life sciences).
• 5+ years direct experience in Supplier Quality Management.
• Demonstrated experience leading supplier audits, SCARs, supplier development and compliance.
• Ability to lead cross-functional teams and influence without authority.

Responsibilities

• Lead supplier qualification, monitoring, auditing, development, and corrective actions.
• Own complex supplier quality issues including Risk 1 suppliers and high‑impact changes.
• Mentor Supplier Quality Engineers and influence cross‑functional stakeholders.
• Support regulatory inspections and notified body audits.
• Drive risk classification, mitigation planning, and supplier performance metrics.

Skills

FDA QSR 21 CFR 820, ISO 13485, EU MDR,

Supplier risk management

Lead cross-functional teams

Root cause analysis, FMEA, statistics

Communications with leadership &外部供应商

ERP and eQMS proficient

Education

Bachelor’s Degree in Life Science or engineering

CQE/ASQ/APICS/Six Sigma preferred

Tools

ERP systems

eQMS systems

Job description

CooperSurgical is seeking a Senior Supplier Quality Engineer to lead supplier qualification, audits, CAPAs, and risk management across critical suppliers. You will mentor junior engineers and partner with regulatory, engineering, and procurement teams to ensure product quality and compliance.

The role requires 7+ years in a regulated quality environment and 5+ years in supplier quality, with expertise in FDA QSR, ISO 13485, EU MDR, and ISO 14971.