Quality Engineer (Medical Device Manufacturing exp req)

Location: Livermore, CA (100% in-office)

Salary: $100,000 - $135,000 + Bonus + Benefits + Equity

Benefits: Fully paid health, dental, & vision plans, Equity Participation, PTO, Sick leave

Job Type: Full-Time

Typical Hours: Monday–Friday, 8:30 AM–5:00 PM

Travel: Less than 25% (audits, conferences, vendor visits)

Start Date: ASAP

Relocation Assistance: Not available

Quality Engineer (Medical Device Manufacturing exp req) Description

Our client, in the medical device industry, is looking for a Quality Engineer to join their team in Livermore, CA. In this role, you will help lead the development and rollout of quality systems that support a recently FDA-approved product set to transform coronary intervention. You’ll be instrumental in building the QMS infrastructure, collaborating across teams, and ensuring compliance with FDA, ISO, and EU MDR standards. The ideal candidate brings experience in QMS implementation and data analysis and is comfortable working hands-on in a startup environment. You’ll have a direct impact on life-saving technology and gain equity in a company heading toward IPO. This is a unique opportunity to join early, grow quickly, and shape the future of a disruptive medical device company with a clear mission and fast-moving trajectory.

Quality Engineer (Medical Device Manufacturing exp req) Responsibilities

• Assist in implementing and maintaining the QMS system

• Develop and update SOPs, protocols, and quality documentation

• Perform inspections and support product testing as needed

• Analyze data and provide reports to support quality initiatives

• Lead and participate in internal and supplier audits

• Assist with design transfer and product development activities

• Maintain documentation for CAPAs, NCRs, and MRBs

• Support risk management and regulatory submissions

• Collaborate with teams to ensure design control deliverables

• Maintain calibration and document control systems

Quality Engineer (Medical Device Manufacturing exp req) Qualifications

• 4+ years of quality engineering experience required

• Medical Devices or related high-precision manufacturing experience required

• Quality Management System experience required

• Data analysis experience required