Quality Engineer III - Medical Devices (Onsite, MN)

ManpowerGroup; Saint Paul (MN); On-site; USD 55,000 - 69,000; Full time

Job summary

ManpowerGroup is seeking a Quality Engineer III for a 12-month, on-site assignment in Saint Paul, MN. The role focuses on supporting medical device quality activities and ensuring compliance with FDA/ISO 13485 and 14971 requirements.

You will perform acceptance testing, develop and review validation master plans, conduct hazard analyses, and assist with SOPs, training, and test protocol execution as needed.

Qualifications

• 3-5 years experience in quality engineering or equivalent field.
• Medical device quality experience in operations or manufacturing is required.
• Strong working knowledge of FDA/ISO regulations such as 13485 and 14971 is essential.

Responsibilities

• Support Quality integration activities including Acceptance Activities and Inspection Plans.
• Perform Data Integrity Risk Assessments (DIRA) and Validation Master Plans (VMPs).
• Lead Hazard Analysis activities and contribute to SOPs and work instructions.
• Occasionally write/execute test protocols and reports.

Skills

Quality engineering experience

Medical device quality

FDA/ISO regulatory knowledge

Ramp up quickly

Job description

ManpowerGroup is seeking a Quality Engineer III for a 12-month, on-site assignment in Saint Paul, MN. The role focuses on supporting medical device quality activities and ensuring compliance with FDA/ISO 13485 and 14971 requirements.

You will perform acceptance testing, develop and review validation master plans, conduct hazard analyses, and assist with SOPs, training, and test protocol execution as needed.