Manager Supplier Quality Medtec

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Quality

Supplier Quality

Professional

Aachen, North Rhine-Westphalia, Germany, Danvers, Massachusetts, United States of America

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Abiomed, part of Johnson & Johnson Med Tech, is a leading provider of medical devices that provide circulatory support, with a mission of recovering hearts & saving lives. Abiomed’ s “Patients First!” culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.

Founded in 1981, Abiomed has a proven track record for growth, integrity, and innovation.

Abiomed Inc. is recruiting for a Commercial Quality (CQ) Supplier Quality Manager, located in Aachen, Germany EMEA or Danvers, MA, USA.The Supplier Quality Manager is responsible for the quality oversight and lifecycle management of suppliers supporting Abiomed Commercial Operations. The portfolio includes suppliers of marketing and promotional materials, printed and digital collateral, translation and localization services, destruction services, commercial transportation, and other outsourced services that may affect product quality, regulatory compliance, brand integrity, or customer experience.

The manager establishes risk-based, fit-for-purpose controls and partners with Commercial, Marketing, Regulatory Affairs, Procurement, Operations, and Quality to ensure externally provided products and services consistently meet approved requirements. This role supports an effective medical device quality management system and promotes compliant, efficient Commercial Operations.

• Own the Commercial Operations supplier quality program, including supplier identification, risk classification, qualification, approval, onboarding, monitoring, requalification, and disengagement.
• Apply risk-based controls appropriate to the supplied product or service, considering potential effects on regulatory compliance, product information, customer communications, patient safety, business continuity, and brand reputation.
• Lead qualification and due-diligence activities, including supplier questionnaires,…