Overview
Quality Engineer (Medical Devices) Jobs in Grand Rapids, MI at Primary Talent Partners
Title: Quality Engineer (Medical Devices)
Company: Primary Talent Partners
Location: Grand Rapids, MI
Primary Talent Partners has an opportunity available for a quality engineer with our large medical device client in Grand Rapids, MI. This is a full-time W2 contract position with an initial duration of 12 months and potential for extension and/or conversion.
Pay Range: $45/hr – $55/hr, no PTO or benefits provided. An ACA-compliant benefits package is available for enrollment.
Job Title: MDR – Quality Engineer
Location: Grand Rapids, MI (Onsite or Hybrid with mandatory onsite days: Monday, Wednesday, Friday)
Work Schedule: Full-time, 40 hours/week
Product Line: Cardiac Surgery
Job Summary
Our client is seeking an experienced Advanced Project Quality Engineering Specialist to support EU MDR (European Union Medical Device Regulation) implementation projects within our Cardiac Surgery product line. This role plays a critical part in ensuring our technical documentation, labeling processes, and quality systems are fully compliant with EU MDR standards. The ideal candidate will have a background in medical device quality engineering and be able to thrive in a fast-paced, collaborative environment.
Must-Have Qualifications
Minimum 2 years of experience as a Quality Engineer in the medical device industry
Strong ability to work efficiently in fast-paced environments
Nice-to-Have Qualifications
Direct experience with EU MDR implementation or remediation projects
Education Requirements
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Biology, or a related field
Key Responsibilities
Lead and support all EU MDR implementation activities for cardiac surgery, including:
Reviewing and approving change orders
Redlining technical documentation
Leading label verification processes in coordination with Grand Rapids QE team
Ensure all EU MDR-related deliverables are completed accurately and on time
Collaborate with cross-functional teams (Engineering, Manufacturing, Quality) to uphold quality standards
Participate in inspections, FAIs, and other relevant activities to support MDR project execution
Support development and execution of IQ, OQ, and PQ protocols as needed
Review labeling, IFUs, and equipment compliance documentation
Drive continuous improvement by identifying and implementing corrective actions where necessary
Ensure compliance with applicable regulations and internal quality system requirements
Work Environment
This position offers the flexibility of onsite or hybrid work arrangements. However, onsite presence is required at least 3 days a week (Monday, Wednesday, Friday) or as per rotation schedules to support project needs.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com
#PTPJobs
