Quality EngineerBrightpath Associates LLC • Hayward, CA, US
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Quality Engineer
Brightpath Associates LLC • Hayward, CA, US
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job_description.job_card.job_descriptionBS in Engineering, Science, or related field; 5+ years of quality experience in Class II / III medical devices (cardiovascular preferred). Deep knowledge of FDA QSR, ISO 13485, MDR, ISO 14971, ISO 10993, and related standards. Experience from product development to commercialization. Strong analytical, communication, and problem-solving skills. Proficient in Microsoft Office; able to travel up to 10%.
Job Description
Position : - Sr. Quality Engineer
Location : - Hayward, CA
Full time
About the Role :
The Sr. Quality Engineer will implement and maintain FDA QSR (21 CFR 820) and ISO 13485 quality systems for the CellFX System and related medical devices, supporting R&D, manufacturing, regulatory, and clinical teams.
Key Responsibilities :
- Provide quality and compliance guidance for product design and manufacturing.
- Develop and maintain quality systems, risk management (ISO 14971), and traceability documentation.
- Manage biocompatibility (ISO 10993) and sterilization (ISO 11135 / 11137) testing.
- Implement process controls, conduct statistical analyses, and support MRB activities.
- Review quality performance data and assist in labeling, UDI, and regulatory submissions.
- Support audits (FDA, Notified Body, MDSAP) and management reviews.
Qualifications :
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Quality Engineer • Hayward, CA, US
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