Medical Device Quality Engineer

Fort Wayne, IN

Job ID: 124145 Industry: Med

Medical Device Quality Engineer

Environment:

Our client a large medical device company that manufacturers class 2 products.

Responsibilities:

Our client is looking for a Quality Engineer focusing on post market surveillance to support a remediation effort. They are looking for someone with experience in the medical device industry. Candidate must demonstrate strong written and oral communication skills and must communicate and document product performance and complaints clearly and concisely using objective evidence and language.  The Quality Engineer will provide support in Review & Approval of Quality Documentation, Batch Record Review & Approval, Quality Investigations, Root-Cause Analysis, Quality Reports, CAPA, Risk Management, Change Control, and Complaints handling. They should have knowledge of medical device regulations as it relates to product performance reporting and complaint handling.

Required:

Medical Device

Four-year scientific degree or current medical licensure

Post Market Surveillance

Complaints/CAPAS

Plus:

Orthopedic Implants

Job Type: Contract

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