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.
...Preferred Skills Field services experience (e.g., repairing ultrasound equipment for a manufacturer). OEM training (e.g., BAXTER training on pumps). CBET (Certified Biomedical Equipment Technician) for Senior level. Technologies/Tools ~ Knowledge of...
Join a global community of talented professionals to shape the future of AI. Earn up to $15 USD/hr and additional rewards based on quality of submission. Outlier is committed to improving the intelligence & safety of AI models. Owned and operated by Scale AI , weve ...
We're Hiring Skilled Video Editors! &##127916; We're looking for experienced video editors proficient in Premiere Pro and fluent in English . &##128205;Location: Junagadh (office-work)
...of helping 1,500 households LiveWell by 2040. Position Summary LiveWell Group (LWG) is seeking an experienced Director of Finance and Administration to provide operational leadership and oversight of the companys financial and human resource functions....
...Middle School Teacher Content areas (History ) International Leadership Charter Middle School is building on 20 successful years of... ...part of a founding team that will inaugurate a new state-of-the-art facility. Additional Application Instructions: Resume must...