Sr Manager, QC & Calibrations
Terumo Medical CorporationAbout the role
Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Senior Manager, Quality Control & Calibration provides strategic leadership for the Quality Control function in Elkton and the Calibration function supporting manufacturing, laboratory, and distribution operations and other select TMC sites. This role is responsible for ensuring sustained compliance with applicable regulatory requirements, the Terumo Quality System, and corporate policies while maintaining effective quality oversight, equipment reliability, and operational performance.
As a member of the Elkton site quality leadership team, the Senior Manager establishes organizational priorities, develops departmental capabilities, and drives continuous improvement through cross-functional collaboration with Manufacturing, Engineering, Operations Quality, Supply Chain, Laboratory, and business leadership. The position is accountable for the overall effectiveness of Quality Control and Calibration systems, processes, personnel, and resources, ensuring inspection readiness, risk management, product quality, and alignment with site and business objectives.
Job Details/Responsibilities
General
Lead and develop Quality Control and Calibration organizations through effective talent management, organizational planning, succession planning, performance management, and employee development initiatives
• Lead and develop the Quality Control and Calibration organizations through talent development, performance management, succession planning, and organizational effectiveness initiatives
• Establish departmental strategy, objectives, budgets, and resource plans aligned with site and business priorities
• Partner with Manufacturing, Engineering, Quality, Laboratory, and Operations leaders to drive operational excellence, quality performance, and continuous improvement
• Monitor operational, quality, compliance, and financial performance metrics to guide decision-making and support achievement of business objectives.
• Lead, coach, and develop people managers and quality professionals to build organizational capability and succession readiness
Compliance
• Ensure sustained adherence to applicable regulatory requirements, the Terumo Quality System, and corporate policies
• Establish and continuously improve policies, procedures, and governance processes that maintain inspection readiness and compliant operations
• Support audits, management reviews, change management, NC/CAPA processes, and compliance risk mitigation activities
• Direct regulatory inspection readiness efforts for QC and Calibration functions and ensure timely, effective resolution of compliance issues and quality system gaps
QC Function
• Provide strategic and operational leadership for Elkton Quality Control activities supporting incoming inspection, in-process inspection, other product appraisal, and final product release testing
• Ensure effective Quality Control systems, processes, and organizational capabilities that support compliant and efficient manufacturing operatio
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