G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) is hiring: Design

Our client in Marlboro, MA is looking to bring on a SR Design QE. This is a direct hire opportunity onsite.

Responsibilities:

• Looking for a Design QE with strong background in Quality Assurance
• Familiar with design controls, risky management and design verification.
• Design disposables such as endoscopes, catheters and other medical devices.
• Conduct product design control activities for new and sustaining product development efforts
• Support risk analysis activities, including design and process FMEA
• Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
• Support Design Engineering in the creation of Design History and Technical Files

Experience:

• 8 years minimum experience in an engineering or quality role in the medical device industry
• Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred
• Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek
• Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.