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Capgemini

Senior Quality Systems Engineer

Capgemini, Sauk Trail Beach, Wisconsin, United States

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Choose a partner with intimate knowledge of your industry and first-hand experience of defining its future.Select your locationSelect your locationIndustriesChoose a partner with intimate knowledge of your industry and first-hand experience of defining its future.Diegem# Senior Quality Systems Engineer## Job DescriptionWe are seeking an experienced **Senior Quality Systems Engineer** to support a strategic project for within our Manufacturing & process unit. The consultant will lead a study focused on separating existing quality systems from a current partner and reintegrating them back into operations.**Key Responsibilities*** Conduct a comprehensive assessment of current quality systems shared with the partner organization.* Develop a detailed plan for system separation and reintegration into our infrastructure.* Collaborate with cross-functional teams to ensure compliance with regulatory and corporate standards.* Provide expert guidance on risk mitigation, data integrity, and system validation during the transition.* Prepare documentation and reports outlining findings, recommendations, and timelines.## Your profile* Master’s degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Biotechnology, or equivalent experience.* Experience: 10–15 years in Quality Systems management and consulting.* Proven track record of managing complex quality system projects in a regulated environment (pharmaceutical or medical device industry preferred).* Strong knowledge of GxP, ISO standards, and regulatory compliance requirements.* Ability to work independently and communicate effectively across global teams.* Excellent communication skills in English & Dutch.**What You Will Love About Working Here*** At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.* Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.* OUTfront, Women@Capgemini or CapAbilityare 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.Experience levelExperienced ProfessionalsLocationDiegem #J-18808-Ljbffr