Quality Systems Specialist - Actalent : Job Details

Job Title: Quality Systems SpecialistJob DescriptionSeeking 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.ResponsibilitiesSupport 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, 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.Essential SkillsProven 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, 21 CFR Part 820, and other applicable software/AI regulations.Quality engineering and software quality experience.Additional Skills & QualificationsDemonstrated 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.Work EnvironmentHybrid environment with 3 days onsite and 2 days remote. This contractor role offers the opportunity to play a vital part in our growth and innovation, ensuring a seamless and compliant integration of Quality Systems across both companies. Benefits include 2-3 weeks of PTO and 6 paid holidays.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] ( [email protected]) for other accommodation options.