Quality Engineer II, Medical Devices | QMS & Compliance

Integer Holdings; Plymouth (MN); On-site; USD 78,000 - 115,000; Full time

Job summary

Integer is seeking a Quality Engineer II to provide quality engineering support for Operations, ensuring compliance with QMS, EMS, FDA regulations, and related standards at our Minnesota facility.

You will guide 1–3 technicians/inspectors, review changes, lead test method validations, support CAPA activities, and collaborate with manufacturing engineers to maintain product quality and regulatory readiness.

Qualifications

• Bachelor's Degree in Engineering or related field required.
• 2–5 years of quality engineering experience in medical device or regulated manufacturing.
• Strong problem-solving and communication skills.

Responsibilities

• Adheres to quality systems and regulatory requirements.
• Support regulatory inspections, audits, investigations, and inquiries regarding design and manufacturing quality.
• Monitor manufacturing of assigned products, ensuring compliance with DMR and proper device history records.
• Review adequacy and correctness of changes to BOMs, assembly procedures, drawings, and specifications.
• Lead generation and completion of protocols and reports for test method validations.
• Coordinate process validations and capability studies with Manufacturing Engineers.
• Develop inspection techniques and procedures for product integrity; write and implement inspection procedures.
• Ensure disposition of non-conforming materials meets regulatory requirements and corrective actions are effective.
• Lead and manage complaint investigations; participate in CAPA activities and continuous improvement.
• Assist with product transfers and support supplier quality and root-cause analysis.

Skills

Communication

Time management

Independent work

Education

Bachelor's degree in Engineering

Tools

Minitab

Microsoft Office

Job description

Integer is seeking a Quality Engineer II to provide quality engineering support for Operations, ensuring compliance with QMS, EMS, FDA regulations, and related standards at our Minnesota facility.

You will guide 1–3 technicians/inspectors, review changes, lead test method validations, support CAPA activities, and collaborate with manufacturing engineers to maintain product quality and regulatory readiness.