Senior Quality Engineer
Confirmed on the employer's own hiring board on Oct 8, 2026. First seen by Alion on Oct 8, 2026.
Join Element Science, a company dedicated to revolutionizing medical technology. As a Senior Quality Engineer, you will play a crucial role in ensuring the quality, reliability, and continuous improvement of our life-saving medical devices. You will work closely with cross-functional teams, provide quality engineering support, and lead the supplier quality program. This is an exciting opportunity to make a significant impact in the medical device industry.
Missions
- Provide Quality Engineering support for product and process changes, nonconformances, CAPAs, complaints, supplier qualification and performance, risk management, and verification and validation activities.
- Lead the supplier quality program, including supplier evaluation, selection, qualification, re-qualification and maintenance of the Approved Supplier List (ASL).
- Analyze quality and product performance metrics to identify trends and drive systemic quality and reliability improvements.
Profil recherché
- The ideal candidate brings strong technical problem-solving skills, sound quality judgment, and a collaborative, hands-on approach to identifying root causes and driving sustainable improvements- 5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products
- Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams
- Bachelor’s degree in Engineering, Science, or a related technical discipline; Master’s degree is a plus
- Excellent written and verbal communication skills
- Strong technical problem-solving and root cause analysis skills
- Strong organizational skills with the ability to manage multiple priorities and consistently complete work on schedule
- Demonstrated experience with post-market and sustaining quality activities, including nonconformances, CAPAs, change control, root cause investigations, and verification and validation
- Working knowledge of ISO 13485, FDA Quality System requirements, ISO 14971, and IEC 60601-1
- Experience applying risk management principles throughout the commercial product lifecycle