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Senior Quality Engineer
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-02-16
Listing for:
BioTalent
Full Time
position Listed on 2026-02-16
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Senior Quality Engineer – Electromechanical Medical Devices
Location:
Alameda, CA (Onsite)
We are seeking a Senior Quality Engineer to support the design, manufacturing, and lifecycle management of complex electromechanical medical devices. This role will partner closely with R&D, Manufacturing, and Operations to ensure product quality, regulatory compliance, and continuous improvement across PCB/PCBA assemblies and finished devices.
Key Responsibilities- Lead quality activities for electromechanical products, including PCB/PCBA assemblies
- Support design controls, risk management (ISO 14971), and product development efforts
- Drive investigations, root cause analysis, and CAPA for quality issues
- Ensure compliance with IEC 60601, FDA QSR (21 CFR 820), and ISO 13485
- Review and approve validation protocols, change controls, and technical documentation
- Collaborate with suppliers on quality performance and corrective actions
- Support audits, inspections, and continuous improvement initiatives
- Bachelor’s degree in Engineering or related field
- 5–10+ years of quality engineering experience in medical devices
- Strong background in electromechanical systems and PCB/PCBA quality
- Working knowledge of IEC 60601, ISO 13485, FDA QSR, and risk management
- Experience with design controls, DHF, and product lifecycle processes
- Hands-on experience with root cause analysis and CAPA
- Experience supporting new product development (NPD)
- Familiarity with supplier quality and manufacturing environments
- Experience with global regulatory submissions or audits
Position Requirements
10+ Years
work experience
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