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.

Responsibilities

• 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
• Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams

Requirements

• 5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products
• 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

Pay

USD 104,000 - 132,000