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. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X.
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 medical device quality, including 5+ years in leadership roles.
- Proven experience with ISO 13485, FDA QSR, and global regulatory frameworks.
- Strong audit management and continuous improvement track record.
- Familiarity with SAP, ETQ, and other global quality platforms.
- Six Sigma certification is a plus.
embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.