Quality Systems Integration Engineer - Impact Business Group

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.

Contract positions

Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment. 

Permanent placed employees

Paid by and qualify for benefits in accordance with the policies of the hiring company. 

Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.

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