Job Title: Sr. Quality Engineer – Medical Device
Location: Northridge, CA (Fully Onsite)
Type: 12-Month W2 Contract
Summary:
We’re seeking an experienced Senior 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.
...other ad hoc projects as assigned Adhere to all HIPAA, privacy, and compliance standards always Qualifications ~ Strong customer service mindset with clear, confident communication skills ~ Team-oriented, proactive, and willing to go above and beyond ~1+ year...
...~ Possess the ability to visualize 2-D drawings in 3-D and explain your means and methods in simple terms. Benefits Include: ~ Full healthcare coverage for the employee, fully paid by the company ~401 (k) matching up to 4%~ Phone and car allowance...
...Spring Street, Mount Pleasant, WI 53405 Register here: We are hiring immediately for full time and part time PATIENT TRANSPORTER positions. Address : All Saints - 3801 Spring Street, Mount Pleasant, WI 53405. Note: online applications accepted only....
...Clayton Services is searching for an Office Assistant to join a thriving company in Northwest Houston. Job Type: Temp-to-Hire Pay Rate: $16.00 - $20.00/hour Schedule: Part-Time or Full-Time Hours Office Assistant Responsibilities: Handle incoming calls promptly...
Village Caregiving is hiring Home Health Aides in and around Norwalk, OH. Home Health Aides are responsible for providing non-medical caregiving services to seniors. We have immediate openings and offer raises.Benefits:* Competitive compensation: $14.00 - $18.00...