Quality Engineer II – Medical Devices

About the role

Integer is seeking a Quality Engineer II to apply advanced quality tools and engineering concepts within the medical device sector. You will work under the guidance of senior engineers to ensure product and process quality meets both internal standards and regulatory requirements.

Key responsibilities

• Support regulatory inspections, audits, investigations, and agency inquiries.
• Monitor manufacturing of assigned products, ensuring compliance with Device History Records (DHR) and providing deviation/waiver guidance.
• 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.
• Collaborate with cross‑functional teams to exchange information and verify understanding.

Required profile

• Engineering background with experience in quality engineering for medical devices.
• Familiarity with FDA regulations, Quality Management Systems (QMS), and device documentation requirements.
• Ability to apply engineering concepts to resolve acute or chronic quality problems.
• Commitment to Integer’s values and adherence to safety, environmental, and security standards.

Required skills

• Quality Management Systems (QMS)
• FDA regulatory knowledge
• Device History Records (DHR) compliance
• Bill of Materials (BOM) review
• Failure Mode and Effects Analysis (FMEA)
• Control Plans development
• Deviation/waiver management
• Continuous‑improvement methodologies

What we offer

• Opportunity to work on innovative medical device products.
• Collaborative environment that values inclusion, candor, and integrity.
• Professional growth through mentorship from experienced engineers.