Senior Design Quality Engineer

The Judge Group

Our client is currently seeking a Senior Design Quality Engineer .This a full-time permanent role with competitive salary + bonus and benefits like 401k match, dental, vision etc.

This job will have the following responsibilities:

Conduct product design control activities for both new product development and sustaining engineering projects.
Support risk management activities, including Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA).

Participate in design and process verification/validation activities, including:
- Design Verification (DV)
- Design Validation (PV)
- Software Validation
- IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance Qualification)
Support Design Engineering in the development and maintenance of:
- Design History Files (DHF)
- Technical Files
- Design specifications
- Verification and validation documentation

Qualifications & Requirements:

Bachelor's degree in Engineering, Science, or a related technical discipline.
Electrical Engineering degree preferred.
5+ years of experience in the design and development of Class II electro-mechanical medical devices.
Experience working within FDA-regulated and ISO-compliant medical device environments.

Apply

Vacancy posted 10 hours ago

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