Quality Engineer II – Medical Devices & Regulatory QA

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

Benefits offered by this job

Medical, dental and vision benefits

401(k) with company matching

Paid holidays and PTO

Job summary

Integer is seeking a Quality Engineer to provide support for Operations, ensuring compliance with QMS, FDA, and ISO requirements in medical device manufacturing. You will lead 1–3 technicians/inspectors and integrate quality engineering into production processes.

Responsibilities include review of BOM changes, validation protocols, CAPA activities, and continuous improvement initiatives, with collaboration across Manufacturing, Engineering, and Supplier teams.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 2–5 years of quality engineering experience in medical device or regulated manufacturing.
• Strong knowledge of ISO/QSR/UL/MDD/TGA standards and FDA regulations.

Responsibilities

• Support Quality System requirements and regulatory inspections.
• Provide work direction for 1–3 technicians/inspectors.
• Develop inspection procedures and ensure device history records.
• Lead CAPA activities and complaint investigations.
• Mentor quality inspectors and technicians.

Skills

Quality engineering

Regulatory knowledge

Communication skills

Statistical methods

Problem solving

Education

Bachelor's Degree in Engineering or related field

Tools

Minitab

Microsoft Office

Job description

Integer is seeking a Quality Engineer to provide support for Operations, ensuring compliance with QMS, FDA, and ISO requirements in medical device manufacturing. You will lead 1–3 technicians/inspectors and integrate quality engineering into production processes.

Responsibilities include review of BOM changes, validation protocols, CAPA activities, and continuous improvement initiatives, with collaboration across Manufacturing, Engineering, and Supplier teams.