Senior Quality Engineer

7 days ago


Bridgeport, United States CooperSurgical Full time

CooperSurgical, Inc. seeks a Senior Quality Engineer in Trumbull, CT, to provide experienced quality assurance leadership and support to the production of CooperSurgical products. Perform quality assurance audits to ensure compliance and optimal manufacturing practices. Develop plans, strategies, and implementation systems to improve manufacturing processes for products. Resolve quality issues with suppliers, provide support for manufacturing transfers to other plants/facilities, and identify, resolve, and escalate quality issues within the plant. Develop Process Failure Mode and Effect Analysis (pFMEA) to manage process risks. Perform various root cause analysis investigations for Complaints, CAPA, Audit Findings, and Non-Conformance Reports.

Requirements: Bachelor's degree in biomedical engineering, or related field, plus 10 years of progressively responsible experience in the medical device industry. Experience must include electronic medical devices (such as defibrillators, patient monitors, sensors, x-ray equipment).

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