Integration Quality Systems Manager

4 days ago


Portage, Michigan, United States Kelly Science, Engineering, Technology & Telecom Full time

We are looking for a highly skilled Integration Quality Systems Manager to support the 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.

Salary: $55 - $74 per hour, depending on experience.

Location: Portage, MI (Hybrid)

Job Type: W2 contract (NO C2C OR THIRD PARTY)

Contract Length: Until 6/2026 (Contract extension expectation)

About the Company:

Kelly Science, Engineering, Technology & Telecom is a leading staffing agency with a reputation for excellence in the medical device industry.

About the Job:
  • The successful candidate will have experience in Software Development Lifecyle (SDLC), Software as Medical Device (SaMD) and/or healthcare IT.
  • Strong analytical and problem-solving skills are required to assess existing Quality Systems and develop integration plans that address gaps.
Responsibilities:
  • Support the integration of Quality Systems between our company and the acquired organization.
  • Collaborate with cross-functional teams from both companies to align Quality System policies, processes, and procedures.
  • Assess existing Quality Systems and develop integration plans that address gaps.
  • 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.
  • 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.


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