Quality System Management Engineer Job Listing at Kelly Services in Portage, MI (Job ID US3572982_BH9863033)

Description

Quality System Management Engineer  

• Location: Kalamazoo, Michigan (49001)
• Duration: 12 month contract (contract extension potential)
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Pay: Negotiable depending on direct-related experience
• Work Authorization: Must be currently in the United States with active employment authorization documents.

 

Summary:

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:

• Manage and analyze customer complaints, warranty claims, and field failures to identify root causes, drive effective corrective actions, and improve product reliability.
• Support the development and assessment of product return process as part of complaint handling.
• Collaborate with cross-functional teams to ensure timely closure and documentation of complaints.
• Develop and deliver regular trend analyses and reports to identify systemic issues and areas for improvement.

 

Quality System Management:

• 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).
• Create, review, and update quality procedures, work instructions, and best practices.
• Consult with various Post Market stakeholders to create and propose process maps that may be used as part of procedure creation.

 

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience).
• 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.

 

Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.

 

 

 

*** (Kelly does not expense relocation/interview costs)**

 

 

• Work Authorization: Must be currently in and able to work in the United States with current employment authorization documents.

 

 

In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:

 

 

 

• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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