Quality Management Specialist
• Location: Portage, MI (Hybrid)
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Length: Until 6/2026 (Contract extension expectation)
• Pay Rate – $55 - $74 hourly depending on experience
• Work Authorization - Must be able to work in the U.S. with approved authorization status.
About the job:
- Seeking a dedicated contractor to support integration activities between our existing company and a recently acquired company, specializing in software and AI-focused products
- This role will be central to our Quality and Regulatory teams, with a primary focus on integrating the Quality Management Systems (QMS) of the two organizations to ensure compliance with relevant industry standards and regulations
Required Education:
What You'll Do:
- Support the integration of Quality Systems between our company and the acquired organization, with a specific focus on regulatory and quality compliance for software/AI products.
- Collaborate with cross-functional teams from both companies to align Quality System policies, processes, and procedures, ensuring consistent and effective integration.
- Assess existing Quality Systems and develop integration plans that address gaps, with special attention to software/AI product requirements.
- Support compliance with regulatory standards such as ISO 13485, 21 CFR Part 820, and other relevant regulations specific to software and AI in the medical device space. Facilitate risk assessments and gap analyses to identify areas needing improvement or harmonization within the combined Quality Systems.
- Ensure alignment with post-market surveillance and product lifecycle requirements unique to software/AI products.
- Provide regular status updates and integration metrics to stakeholders.
Qualifications:
- Proven experience in Quality Systems management within the medical device industry, particularly with software or AI-driven products.
- Experience in Software Development Lifecyle (SDLC), Software as Medical Device (SaMD) and/or healthcare IT preferred
- Strong understanding of regulatory standards, including ISO 13485, 21 CFR Part 820, and other applicable software/AI regulations.
- Demonstrated experience in managing Quality System integrations post-acquisition. Excellent communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.
- Ability to analyze complex Quality System structures and recommend practical integration strategies.
Important information:
- To be immediately considered, please send an updated version of your resume to ...@kellyservices.com
- *** (Kelly does not expense relocation/interview costs) **
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