Quality Engineer II – Medical Device Manufacturing

About the role

Integer is seeking a Quality Engineer II to support the design and manufacturing of medical device products. You will apply advanced quality tools and engineering concepts to ensure compliance with internal standards and regulatory requirements.

Key responsibilities

• Support regulatory inspections, audits, investigations, and agency inquiries.
• Monitor manufacturing processes, ensure compliance with Device Master Records (DMR), and guide deviation/waiver actions.
• Review and validate changes to Bills of Materials, assembly procedures, drawings, component specifications, FMEAs, and control plans.
• Participate in continuous‑improvement projects and assist with product transfers.
• Execute technical projects following Integer’s quality management and production system methodologies.

Required profile

• Engineering mindset with the ability to resolve acute or chronic quality issues.
• Adherence to company values, safety, environmental, security, and quality standards.
• Ability to work under guidance from senior engineers and collaborate across functions.

Required skills

• Knowledge of Quality Management Systems (QMS) and FDA regulations.
• Experience with Device History Records (DHR) and Device Master Records (DMR).
• Proficiency in reviewing Bills of Materials, FMEAs, and Control Plans.
• Capability to manage deviations, waivers, and product change documentation.

What we offer

• Opportunity to work on cutting‑edge medical device technologies.
• Collaborative environment focused on innovation and continuous improvement.