Quality Engineer II

Founded in 1988 and headquartered in Milpitas, CA, Stellartech Research Corporation (SRC) is a world leader in developing innovative medical devices for large companies and early-stage start-ups. Our systems combine sophisticated electronics with "smart" disposables, leveraging cutting-edge energy delivery, cloud-based wireless communication, and advanced imaging to pioneer medical breakthroughs.

Stellartech seeks a Quality Engineer to support projects that advance our mission of delivering medical systems. The role reports to the Director of Design QA and is an on-site position at our Milpitas, CA facility.

• Perform quality engineering development activities for new product designs, assisting Engineering with design and development plans, Design History File documentation, and preparation.
• Review and approve Device Master Record documentation for new product design and maintenance, including bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operators' manuals.
• Conduct ongoing quality engineering activities on current products to improve designs and/or manufacturing processes, including participation in NCM, Complaint, and CAPA investigations.
• Assist in process validation activities for new and current products.
• Support maintenance and improvement of the Quality System, including internal audits, external audits, and quality improvement activities.
• Assist Engineering in preparing and executing verification and validation protocols and reports for new products and changes to current products.
• Participate in Hazard Assessment, Failure Mode and Effect Analysis, and risk management analysis, as required.
• Assist in preparing regulatory submissions to the U.S. FDA and other regulatory agencies.
• Review and approve Device History Records for products finished device release as required.
• Serve as a technical resource for technicians, assemblers, and other Stellartech personnel.
• Perform other duties as directed by the Supervisor.

• BS degree or equivalent.
• At least 1-3 years of relevant experience.
• Participation in ASQ is desired.

Salary Range: $,000 annually.

We offer a competitive benefits package to full-time employees, including medical, dental, vision, life and disability insurance, paid time off, a 401(k) plan with company match, and a stock equity plan.