Quality Engineer Medical Device/SS

Sr. Product Quality Engineer

Location: Alameda, CA – Onsite
Contract Duration: Through March 31, 2027
Work Hours: 8:00 AM – 5:00 PM
Employment Type: Non-Exempt

Job Summary

We are seeking a Sr. Product Quality Engineer to provide engineering and quality support to manufacturing operations. The ideal candidate will have experience in an ISO 9001 environment, preferably within the medical device industry, and strong knowledge of quality systems, process improvement, validation, and statistical techniques.

Key Responsibilities

• Provide engineering support to In-Process Inspectors and manufacturing operations.
• Support production activities and process improvement initiatives.
• Perform trend analysis, process validation, and Statistical Process Control (SPC).
• Coordinate In-Process Material Review Board (MRB) activities.
• Support Quality System activities, including internal audits, SOP improvements, and employee training.
• Participate in CAPA investigations and corrective action activities.
• Support the successful transfer of new products from R&D to Production from a Quality perspective.
• Apply and interpret statistical techniques and SPC data.
• Prepare and present Product Performance Reviews (PPR) and Management Reviews.
• Collaborate with Engineering, Manufacturing, R&D, and Quality teams to ensure product and process compliance.
• Ensure manufacturing processes meet applicable quality and regulatory requirements.

Required Qualifications

• Bachelor’s degree or higher in Mechanical Engineering, Industrial Engineering, or an equivalent engineering discipline.
• 2+ years of industry experience in an ISO 9001 environment.
• Medical device industry experience is strongly preferred.
• Experience with Quality Engineering and manufacturing processes.
• Knowledge of CAPA, MRB, SPC, process validation, audits, and quality systems.
• Strong analytical, problem-solving, and communication skills.
• Ability to work onsite in Alameda, CA, Monday through Friday, 8:00 AM–5:00 PM.

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.