Quality Engineer II

About the role

Integer is seeking a Quality Engineer II to apply engineering concepts and advanced quality tools within the medical device manufacturing environment. You will work under guidance from senior engineers and managers to ensure product and process quality meets both internal and external customer expectations.

Key responsibilities

• Support regulatory and agency inspections, audits, investigations, and inquiries related to product design and manufacturing quality.
• Monitor manufacturing of assigned products, ensure compliance with Device Master Records (DMR), provide deviation/waiver guidance, and maintain complete Device History Records.
• 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 to identify product and process improvements.

Required profile

• Ability to apply engineering concepts to solve acute or chronic quality problems.
• Familiarity with Quality Management Systems (QMS) and FDA regulatory requirements.
• Commitment to adhere to safety, environmental, security, and quality standards.
• Willingness to collaborate, ask questions, and verify understanding with cross‑functional teams.

Required skills

• Knowledge of QMS and FDA regulations.
• Experience with Device History Records and Device Master Records.
• Understanding of Bills of Materials (BOM), FMEAs, and Control Plans.
• Proficiency in using advanced quality tools and concepts.

What we offer

• Opportunity to work in a global organization focused on innovative medical device technologies.
• Engagement with continuous‑improvement initiatives and cross‑functional projects.