G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing)
G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) | Design Quality
G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing), New York, New York, United States
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.
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.