Job Title: Sr. Design Quality Engineer – Medical Device
Location: Northridge, CA (Fully Onsite)
Type: 12-Month W2 Contract
Summary:
We’re seeking an experienced Senior Design Quality Engineer to support the full product development lifecycle for implantable and electro-mechanical medical devices. The ideal candidate will have strong expertise in Design Controls, Risk Management (FMEA, Hazard Analysis), and Validation (TMV, IQ/OQ/PQ), ensuring compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU-MDR standards.
Key Skills:
• Design Control & Regulatory Compliance (ISO 13485, 21 CFR 820, EU-MDR)
• Risk Management (FMEA, Hazard Analysis)
• Electro-mechanical
• Design Verification & Validation Testing
• Process Validation (TMV, IQ/OQ/PQ)
• Supplier Qualification & Design Transfer
• Problem Solving / CAPA / Continuous Improvement.
Preferred:
• Experience with IEC 62304 and IEC 60601-1
• ASQ Certification (Quality/Reliability)
• Strong communication & documentation skills.
Qualification:
• Bachelor’s in Engineering/Science with 5+ years, or Master’s with 3+ years in Quality/Engineering.
Position Summary: The Registered Nurse (RN) provides professional, comprehensive nursing care for patients in an acute care environment. Accountable for the delivery of coordinated, safe, compassionate, therapeutic, evidence based quality care to patients and families...
...execution. Coordinate with architects, engineers, subcontractors, and stakeholders to ensure project goals are met. Oversee contract negotiations, risk management, and compliance with local regulations and safety standards. Monitor project progress, resolve issues...