Quality Systems Integration Engineer

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Systems Integration Engineer for an 18 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

 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.

Position Description (Principle Duties and Responsibilities)

• 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.

• 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.
• This contractor role offers the opportunity to play a vital part in our organization's growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies.