NEW JOB OPENING
SENIOR QUALITY ASSURANCE ENGINEER
IN PORTAGE, MI, USA!

 

Date Posted: 06/06/2025
Hiring Organization: Rose International
Position Number: 483800
Industry: Medical Equipment & Supplies
Job Title: Senior Quality Assurance Engineer
Job Location: Portage, MI, USA, 49002
Work Model: Onsite
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 13
Min Hourly Rate($): 50.00
Max Hourly Rate($): 60.00
Must Have Skills/Attributes: Data Analysis, Engineering, Quality Assurance
Experience Desired: ExpDe::Quality Engineering within the medical device or regulated industry (Yrexp::5 yrs); ExpDe::Quality system regulations (Yrexp::5 yrs); ExpDe::Post-market quality assessment (Yrexp::1 yrs)
Required Minimum Education: Bachelor’s Degree
Preferred Education: Master’s Degree

 

Job Description
Required Education:
• Bachelor’s degree in Engineering, Life Sciences, or related field (or equivalent experience).

Required Experiences and Skills:
• 3+ years of experience in Quality Engineering within the medical device, pharmaceutical, or related regulated industry.
• Strong knowledge of quality system regulations (ISO 13485, 21 CFR Part 820)
• Experience with complaint handling, CAPA, and nonconformance management.
• Excellent problem-solving, data analysis, and communication skills.

Senior Quality Assurance Engineer Responsibilities:
We are seeking a dedicated Senior Quality Assurance Engineer with strong Quality System experience to join our integration team. In this role, you will support post-market surveillance, complaint handling, and continuous improvement activities while ensuring compliance with regulatory requirements. As part of a recent acquisition of a software technology company, this individual will support activities to integrate this new business with an existing medical device quality system. Experience with software products and non-medical devices is preferred to assist in the post-market assessment activities and quality system integration.

Key Responsibilities:
• Complaint Management and Issue Resolution:
o Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
o Support the development and assessment of product return process as part of complaint handling.
o Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
o Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.
• Quality System Management:
o Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with industry standards (e.g., ISO 9001, ISO 27001, TL 9000).
o Create, review, and update quality procedures, work instructions, and best practices.
o Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.
o



  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

 

Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

 

 

About Rose

  • Founded in 1993
  • Office Locations Across the U.S.
  • 150+ Clients: Corporations and Government Agencies
  • Employee Oriented Company
  • Challenging Assignments Across the U.S.
  • Continuous Professional Development

As a contractor, I have to say that Rose International was by far the best agency I have worked for.

Q'testdalir, Consultant

Thanks for the opportunity. If in the future I ever need a job, I would like to work for Rose International.

David, Consultant

I believe the best thing that Rose HR has going for it is the incredible responsiveness. Everyone is very quick to reply to any concerns, and contacts the contracted employees very quickly and efficiently.

Kevin, Consultant

It is a great pleasure being a part of the Rose International Team.

Toni, Consultant

Rose International was not only attentive and responsive, but they were very professional and helpful whenever I called or needed any assistance.

Diane, Consultant

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