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Objectives of Position

The Manager Supplier Quality Engineering is responsible for the disciplinary lead and management of Supplier Quality Engineers related to a specific category of suppliers. The position holder is responsible for all supplier quality related activities for their designated category.

Assignments/Tasks

• Ensuring supplier compliance to all applicable quality system regulations.

• Ensuring reliable quality of supplier provided direct material and services.

• Collaborate with supplier engineering, design engineering and quality inspection to ensure that all required supplier quality processes are in place, verified and controlled.

• Represent QA on Engineering Change Orders (ZEC), Material Review Board (MRB) and Deviations.

• Gather data and report on supplier quality metrics

• Support supplier audits and associated activities.

• Support internal- and external quality audits.

• Investigate and review supplier quality related nonconformities; ensure root cause investigations are thorough and corrective / preventive actions implemented and effective.

Authorities of Job Owner

Quality decisions in areas of: Nonconformance management, Supplier change management, Supplier part qualifications, Supplier Audit follow up, Supplier corrective action (SCAR) and Corrective and preventive action (CAPA) activities. Supplier related engineering change requests, supplier audit follow up

Collaboration with other departments

Supplier quality Engineering Danvers, Design Quality Engineering, Quality Systems, Supplier Engineering, Life Cycle Engineering, Manufacturing Quality Engineering

Requirements

• University degree in Engineering discipline

• Min 5 years of quality engineering

• Good understanding of FDA QSRs, ISO13485

• Experience with handling of non-conforming material including root cause investigations

• Experience with statistical data analysis

• MS Office usage, experience with SAP is a plus