Senior Supplier Quality Engineer

CooperSurgical; Trumbull (CT); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is a leading fertility and women’s healthcare company. The Supplier Quality Engineer II role is based in Trumbull, CT (on-site) and leads SCAR, SCN and supplier nonconformance processes, supplier development activities and risk assessments to ensure quality across supplier networks.

This role collaborates with Quality, Engineering and Purchasing, drives supplier audits, changes, and validation activities while sustaining supplier quality programs and ensuring regulatory

Qualifications

• 3+ years in regulated quality environment.
• 3+ years in working with Supplier Management processes.
• Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skillset.
• CQE, APICS, Green Belt or Black Belt certifications are a plus.

Responsibilities

• Manage Supplier Quality sustaining activities.
• Facilitate supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).
• Act as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS and other relevant requirements at partner suppliers/vendors in order to support operations and development engineering.
• Work with Value Streams, Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).
• Support development & implementation of supplier quality program by: Supplier on-going monitoring and re-evaluation process.
• Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.
• Create/ Maintain supplier quality agreements.
• Support all Procurement supplier Projects.
• Support all new Product Development that is intended for production at suppliers.
• Support all business continuity projects at suppliers.
• Update SOPs and Forms related to supplier management process as needed.
• Support internal and external QMS audits, and work as a key player in the audit’s backup or inspection rooms.
• File and maintain Supplier related documentation as per QMS.
• Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers and implement mitigating processes at Cooper sites, as needed.
• Collaborate with Quality Engineers, Inspectors, Value Streams, and Purchasing teams.
• When required, submit Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs, and review Supplier responses for appropriate root-cause analysis and Corrective Actions to prevent reoccurrence of failure modes.
• Support supplier validation activities as required from Supplier Quality prospective.
• Support transfer projects and Supplier localization projects.
• Support IQ, OQ, PQ and PPAP processes.
• Perform other duties as assigned.

Skills

FDA QSR

ISO 13485

Supplier management

Auditing

Communication

MS Office

ERP systems

Education

Bachelor’s degree in Life Science or related field

CQE / APICS / Belt certification

Tools

ERP systems

QMS software

Minitab

MS Office

Job description

CooperSurgical is a leading fertility and women’s healthcare company. The Supplier Quality Engineer II role is based in Trumbull, CT (on-site) and leads SCAR, SCN and supplier nonconformance processes, supplier development activities and risk assessments to ensure quality across supplier networks.

This role collaborates with Quality, Engineering and Purchasing, drives supplier audits, changes, and validation activities while sustaining supplier quality programs and ensuring regulatory