Quality Management Specialist

1 day ago


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

We are seeking a skilled Quality Management Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. This role is crucial in ensuring the integration of Quality Systems between our company and an acquired organization.

The successful candidate will have experience in managing Quality Systems within the medical device industry, particularly with software or AI-driven products.

This position requires strong communication and project management skills, with the ability to work cross-functionally and facilitate effective collaboration between teams.

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 Job:
  • The primary focus of this role will be on integrating the Quality Management Systems (QMS) of the two organizations to ensure compliance with relevant industry standards and regulations.
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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