Quality Engineer II - Electronics

Quality Engineer II - Electronics - Medical Device Manufacturing

Full-Time W2

Location:
Alameda California

Benefits: Medical, dental, vision, 401(k), paid holidays, 15+ days PTO, parental leave, disability, and life insurance.

Join a global leader in innovative medical technologies. If you’re passionate about improving patient outcomes and ensuring uncompromising product quality, this role offers the opportunity to make a real impact.
Exposure to complex, life‑saving electromechanical devices

Responsible for developing, implementing, and maintaining quality system elements to support both new and existing medical device products.

You will support electronics‑heavy, electromechanical Class II & III medical devices, working closely with R&D, Electrical Engineering, and Manufacturing teams. This role centers on design controls, risk management, and hands‑on electronics quality support.

This role is on‑site and part of a mission‑driven organization transforming patient care.

• Associate’s or Bachelor’s in Engineering
  , Life Sciences, or related field.
• 4+ years of experience in quality engineering or similar roles, ideally in medical devices or other regulated industries.
• Electromechanical medical device experience (Class II or III)
• Familiarity with QSR, ISO
  , and related regulations.

• Experience working with electronic devices and PCBAs
  .
• Strong communication skills—verbal, written, and interpersonal.
• Proficiency with MS Word, Excel, Power Point .
• IEC 60601, Risk Management (ISO 14971, FMEA, hazard analysis)
• PCB / PCBA experience

• Support qualification and development activities for new and existing electromechanical products.
• Develop testing and inspection methodologies and documentation.
• Design QC sampling systems, statistical techniques, and inspection mechanisms.
• Perform failure analysis and defect investigations.
• Electromechanical and electronic medical devices

• Partner cross‑functionally with R&D, Electrical Engineering, and Manufacturing
• Recommend specification revisions and analyze production limitations.
• Participate in Quality Objective teams.

• Develop SOPs and facilitate internal audits.
• Ensure compliance with IEC 60601 and relevant safety standards
• Participate in failure analysis of electronic assemblies
• Ensure compliance with Quality Management System (QMS) and global regulatory requirements.
• Promote adherence to security, privacy, and compliance standards.
• Ensure departmental compliance with QMS, regulations, and standards.

• Support additional work‑related tasks as assigned.
• Ability to lift up to 25 lbs and move between buildings/floors.