BioTalent
Senior Quality Engineer – Medical Device
Location:
SF Bay Area, CA (Onsite)
Full time permanent position
Base salary, bonus, benefits, and equity
This company does not offer visa sponsorship, and candidates must already have permanent work authorization in the U.S.
Base pay range $120,000.00/yr - $150,000.00/yr
The Senior Quality Engineer will support product development, manufacturing, and regulatory activities for Class II/III medical devices. This role plays a key part in maintaining and improving the Quality Management System while partnering closely with R&D, Operations, Regulatory, and Clinical teams.
Key Responsibilities
Provide quality engineering support across design controls, design assurance, and risk management
Maintain compliance with FDA QSR (21 CFR 820) and ISO 13485 requirements
Lead risk management activities in accordance with ISO 14971
Develop and maintain requirements traceability matrices
Support biocompatibility, sterilization, and packaging validation activities
Establish and improve process controls and quality engineering practices
Participate in MRB, CAPA, audits, and management reviews
Support regulatory inspections and submission readiness as needed
Qualifications
Bachelor’s degree in Engineering, Science, or related field
5+ years of Quality Engineering experience in the medical device industry
Experience with Class II or III devices required
Strong working knowledge of FDA QSR, ISO 13485, and MDR
Hands‑on experience supporting products from development through commercialization
Experience in a startup or fast‑growth environment strongly preferred
Excellent communication skills and ability to work cross‑functionally
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance and Engineering
Industries Medical Equipment Manufacturing, Biotechnology Research, and Staffing and Recruiting
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SF Bay Area, CA (Onsite)
Full time permanent position
Base salary, bonus, benefits, and equity
This company does not offer visa sponsorship, and candidates must already have permanent work authorization in the U.S.
Base pay range $120,000.00/yr - $150,000.00/yr
The Senior Quality Engineer will support product development, manufacturing, and regulatory activities for Class II/III medical devices. This role plays a key part in maintaining and improving the Quality Management System while partnering closely with R&D, Operations, Regulatory, and Clinical teams.
Key Responsibilities
Provide quality engineering support across design controls, design assurance, and risk management
Maintain compliance with FDA QSR (21 CFR 820) and ISO 13485 requirements
Lead risk management activities in accordance with ISO 14971
Develop and maintain requirements traceability matrices
Support biocompatibility, sterilization, and packaging validation activities
Establish and improve process controls and quality engineering practices
Participate in MRB, CAPA, audits, and management reviews
Support regulatory inspections and submission readiness as needed
Qualifications
Bachelor’s degree in Engineering, Science, or related field
5+ years of Quality Engineering experience in the medical device industry
Experience with Class II or III devices required
Strong working knowledge of FDA QSR, ISO 13485, and MDR
Hands‑on experience supporting products from development through commercialization
Experience in a startup or fast‑growth environment strongly preferred
Excellent communication skills and ability to work cross‑functionally
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance and Engineering
Industries Medical Equipment Manufacturing, Biotechnology Research, and Staffing and Recruiting
#J-18808-Ljbffr