Medical Device Validation Engineer

Rochester, NY

Job ID: 121439 Industry: Quality

Medical Device Validation Engineer

Environment:

Our client is a large medical device manufacturer. They manufacturing a number of Diagnostic Devices. They are in need of a Validation Engineer to come in and join the external manufacturing team.

Principle Duties and Responsibilities:

The consultant will come from a manufacturing background for medical devices.  Looking for someone who can come in and ensure compliance to quality system requirements. Provide oversite and approvals of suppliers facilities, equipment, and process changes. Provide oversite and approval of suppliers commissioning, qualification, verification and validation plans/ protocols and reports. This person will also be ensuring effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues. Provide design control, change control and validation guidance and leadership to business partners.

Should have experience with Six Sigma techniques, Failure mode and analysis (FMEA) and Fault Tree Analysis.

Required Skills:
  • Medical Device
  • Quality System Regulation
  • Process Validation
  • Statistical Analysis
  • DOE experience

Job Type: Contract  

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