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Senior Quality Systems Manager

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Senior Quality Systems Manager

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. Senior Manager, Global Quality Systems Are you passionate about quality and compliance? embecta is seeking a Senior Manager to lead and standardize global quality systems, ensuring regulatory compliance and driving continuous improvement across our distribution and regional operations. Key Responsibilities Oversee global quality systems in compliance with ISO 13485, 21 CFR 820, GDP, and regional regulations (e.g., MDD, MDR, IVDR). Conduct regular on-site quality oversight at the regional Distribution Center, with travel required approximately once or twice per month (to ensure compliance with quality systems, support continuous improvement initiatives, and maintain inspection readiness. ) Lead internal and external audit preparation, execution, and follow-up. Represent embecta during FDA, ISO, and other regulatory inspections. Identify and mitigate quality risks in logistics and warehousing. Ensure importer compliance and post-market surveillance effectiveness in EMEA. Drive initiatives to enhance quality performance, reduce non-conformities, and streamline processes using methodologies like Lean or Six Sigma. Govern training plans, ensure associate compliance, and promote awareness of regulatory and QMS requirements across the organization. Track and communicate quality KPIs, including defect rates, audit findings, and issue resolution cycle times. Support strategic planning and continuous improvement goals. Mentor and develop the quality systems team. Build organizational capability and foster cross-functional collaboration with regulatory, operations, and commercial teams. Maintain up-to-date quality documentation and records. Establish and revise procedures and metrics to support global quality objectives. Qualifications Bachelor's degree in STEM or other discipline (Master's preferred). 7+ years in med... Global Quality, FDA, Execution, KPI, Documentation, Regional Operations, Conflict Management, Cross Functionality, ISO Standards, Strategic Planning, Total Rewards, Empowering Others, ISO13485, Inspection, Regulation, Passion, Training, Design, Quality systems, Audit findings, Communication, VOS, Metric, External Audit, Operations, Methodology, Distribution Center, Lean Six Sigma, Warehouse logistics, Streamline, Distribution

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