Commercial Quality Manager Supplier Quality

Commercial Quality Manager Supplier Quality

About MedTech

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 https://www.jnj.com/medtech

About Cardiovascular

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.

About Abiomed

Abiomed, part of Johnson & Johnson MedTech, 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.

Key Responsibilities

• 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, capability assessments, quality system reviews, audits, sample evaluations, and approval recommendations.
• Establish and maintain supplier quality requirements in specifications, statements of work, purchase documents, and quality agreements, including responsibilities for change notification, record retention, traceability, confidentiality, subcontractor controls, issue escalation, and regulatory support.
• Partner with Marketing, Regulatory Affairs, Medical Affairs, Legal, Procurement, and Commercial Operations to ensure suppliers reproduce and distribute only approved content and materials, with appropriate version, artwork, proof, print, translation, labeling, and fulfillment controls.
• Provide quality oversight for marketing and promotional material suppliers, including agencies, printers, digital production vendors, translation providers, fulfillment houses, and destruction vendors.
• Define and oversee acceptance activities for supplied materials and services, including proof approval, first-article or sample review, reconciliation, release documentation, and verification of destruction when applicable.
• Monitor supplier performance using quality, delivery, service, responsiveness, audit, deviation, and change-control metrics; conduct periodic business and quality reviews and escalate adverse trends.
• Lead or approve supplier-related nonconformance investigations, root-cause analyses, corrective and preventive actions, effectiveness checks, and risk-based disposition decisions.
• Assess proposed supplier, process, material, site, technology, and subcontractor changes; ensure appropriate review and approval before implementation.
• Plan and conduct supplier audits, document findings, agree corrective actions, verify sustainable closure, and maintain inspection-ready records.
• Maintain the approved supplier list and accurate supplier-quality records in applicable quality and procurement systems.
• Support internal audits, external inspections, and regulatory or notified-body requests related to supplier controls and Commercial Operations.
• Identify and manage supplier continuity risks, including capacity, sole-source exposure, data security, records availability, and contingency planning.
• Develop procedures, work instructions, training, templates, and governance that clarify quality expectations for business partners and suppliers.
• Serve as the quality business partner to Procurement and Commercial Operations, balancing compliance, speed, cost, and customer needs without compromising approved requirements.
• Drive continuous improvement through supplier development, standardized controls, data analysis, and corrective action prevention.

Qualifications

Education

• Required: Undergraduate degree in science, engineering, or a related scientific field.
• Preferred: Master’s degree in business, science, engineering, or a related scientific field.

Experience and Skills:

Required:

• Typically 7 or more years of experience in Quality, Supplier Quality, Commercial Quality, Regulatory Compliance, Operations, or a related function within medical devices, pharmaceuticals, diagnostics, or another highly regulated industry.
• Demonstrated experience qualifying and managing external suppliers or service providers through their full lifecycle.
• Working knowledge of medical device quality system requirements, supplier controls, risk management, change control, nonconformance, CAPA, document control, and audit practices.
• Knowledge of ISO 13485 and applicable regulatory requirements, including the FDA Quality Management System Regulation, is strongly preferred.
• Experience drafting and negotiating quality agreements, supplier requirements, and quality clauses in business contracts.
• Proven ability to lead supplier audits, investigations, CAPAs, performance reviews, and cross-functional risk decisions.

Preferred:

• Experience with marketing, promotional, print, translation, labeling, fulfillment, logistics, or other indirect/commercial suppliers is preferred.

• Experience working in global, matrixed, and multicultural organizations is preferred.

• Core Competencies

• Strong judgment and practical application of risk-based quality principles.

• Ability to influence outcomes and resolve trade-offs without direct authority.

• Clear written and verbal communication with internal leaders and external suppliers.

• Strong negotiation, relationship management, conflict resolution, and collaboration skills.

Work Environment and Benefits:

• Hybrid Work model across locations in Danvers, MA, USA and Aachen, Germany.

• Note: This description reflects the general nature and level of work and is not a commitment to a particular role or sequence of events.