Commercial Quality Manager Supplier Quality

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Cardiovascular

Are you passionate about improving and expanding the possibilities of Cardiovascular Ready to join a team thats 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.

• 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.

Education:

Required: Undergraduate degree in science engineering or a related scientific field.

Preferred: Masters degree in business science engineering or a related scientific field.

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 escalation skills.
• Analytical mindset with the ability to translate data and trends into action.
• High attention to detail document accuracy and version control.
• Ability to manage multiple priorities in a fast-paced commercial environment.
• Customer-focused hands-on approach with accountability for timely results.
• Ability to make complex quality requirements clear and actionable for non-quality audiences.

Working Requirements

• Ability to travel domestically and internationally up to approximately 20% including supplier and audit locations.
• Fluent written and spoken English; additional language capability is an asset.
• Role may require participation in time-sensitive supplier escalations across global time zones.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:
Vacation 120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
Holiday pay including Floating Holidays 13 days per calendar year
Work Personal and Family Time - up to 40 hours per calendar year
Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year

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