Senior Quality Engineer

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.

• 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.

• 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