Quality Engineer II – Medical Devices & Compliance

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

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid holidays

Parental leave after one year

Job summary

Integer in Plymouth, MN seeks a Quality Engineer II to provide quality engineering support for Operations in medical device manufacturing. This role ensures compliance with QMS, EMS, FDA regulations and regulatory requirements, while guiding 1–3 technicians/inspectors.

You will review design changes, validation protocols, and CAPA activities; drive process improvements and mentor the quality team to ensure product integrity and quality system effectiveness.

Qualifications

• Bachelor’s degree in engineering or related field.
• 2–5 years quality engineering experience in medical devices or regulated manufacturing.
• Knowledge of QMS, FDA regulations and quality tools like DOE, CAPA.

Responsibilities

• Provide quality engineering support to ensure regulatory compliance for medical device manufacturing.
• Review BOMs, assembly procedures, drawings and control plans for accuracy.
• Lead protocols, tests and reports for method validations and CAPA activities.
• Mentor inspectors and technicians; assist with process validations and transfer projects.
• Support inspections, deviations, root-cause analysis and continuous improvement.

Skills

Teamwork

Communication

Time management

Independent work

Analytical thinking

Education

Bachelor’s Degree in Engineering or related field

Tools

Minitab

Microsoft Office

Job description

Integer in Plymouth, MN seeks a Quality Engineer II to provide quality engineering support for Operations in medical device manufacturing. This role ensures compliance with QMS, EMS, FDA regulations and regulatory requirements, while guiding 1–3 technicians/inspectors.

You will review design changes, validation protocols, and CAPA activities; drive process improvements and mentor the quality team to ensure product integrity and quality system effectiveness.