Senior Quality Engineer

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

$/yr - $/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 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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