Supplier Quality Engineer II: Global Compliance & Development

CooperSurgical; Livingston (NJ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Paid time off

Job summary

CooperSurgical is seeking a Supplier Quality Engineer II to lead supplier quality programs and drive continuous improvement with suppliers. You will manage SCAR/SCN processes and collaborate with Engineering, Quality, and Purchasing teams to ensure compliance with FDA QSR, ISO 13485 and CMDCAS requirements.

The role involves supplier audits, development activities, and cross-functional risk assessment. Travel up to 25% may be required, and a Bachelor’s degree in Life Science or Engineering is

Qualifications

• Bachelor’s degree in Life Science, Engineering or related field.
• CQE, APICS, Green Belt or Black Belt certifications are a plus.
• 3+ years in a regulated quality environment.

Responsibilities

• Lead SCAR, SCN and supplier nonconformance processes.
• Drive supplier development and risk assessments.
• Perform supplier audits and site visits as needed.
• Maintain supplier quality agreements and related documentation.
• Support IQ, OQ, PQ and PPAP processes.
• Collaborate with Quality, Engineering and Purchasing teams.
• Provide metrics for Management Review.

Skills

Regulatory knowledge

Quality systems

Supplier management

Auditing

Communication

ERP experience

QMS systems

Education

Bachelor's in Life Science or Engineering

Tools

MS Office

Minitab

ERP systems

QMS systems

Job description

CooperSurgical is seeking a Supplier Quality Engineer II to lead supplier quality programs and drive continuous improvement with suppliers. You will manage SCAR/SCN processes and collaborate with Engineering, Quality, and Purchasing teams to ensure compliance with FDA QSR, ISO 13485 and CMDCAS requirements.

The role involves supplier audits, development activities, and cross-functional risk assessment. Travel up to 25% may be required, and a Bachelor’s degree in Life Science or Engineering is