Commercial Quality Manager Supplier Quality (Medical Devices)

Location: Aachen, Germany, or Danvers, Massachusetts, United States. Travel domestically and internationally up to approximately 20% is required, including supplier and audit locations.

Base pay: €78,300–€135,700 per year, plus annual bonus and benefits.

Company

Johnson & Johnson MedTech develops medical technologies and treatments, with this role supporting Abiomed’s cardiovascular medical-device business.

What you will do

• Own the Commercial Operations supplier quality program, including supplier risk classification, qualification, approval, onboarding, monitoring, requalification, and disengagement.
• Lead supplier due diligence, capability assessments, quality-system reviews, audits, sample evaluations, and approval recommendations.
• Establish supplier quality requirements in specifications, statements of work, purchase documents, and quality agreements.
• Oversee suppliers of marketing and promotional materials, printed and digital content, translation, labeling, fulfillment, transportation, and destruction services.
• Monitor supplier performance and lead investigations, root-cause analyses, CAPAs, effectiveness checks, change assessments, and risk-based disposition decisions.
• Maintain inspection-ready supplier records, support audits and regulatory inspections, and drive supplier continuity and continuous-improvement activities.

Requirements

• Undergraduate degree in science, engineering, or a related scientific field.
• Typically 7 or more years of experience in quality, supplier quality, commercial quality, regulatory compliance, operations, or a related function in a highly regulated industry.
• Experience managing external suppliers through their full lifecycle and drafting or negotiating quality agreements and supplier requirements.
• Working knowledge of medical-device quality systems, supplier controls, risk management, change control, nonconformance, CAPA, document control, and audits.
• Knowledge of ISO 13485 and applicable regulatory requirements, including FDA Quality Management System Regulation, is strongly preferred.
• Fluent written and spoken English required. Availability for time-sensitive supplier escalations across global time zones is expected.

Nice to have

• Master’s degree in business, science, engineering, or a related scientific field.
• Experience with marketing, promotional, print, translation, labeling, fulfillment, logistics, or other indirect and commercial suppliers.
• Experience in global, matrixed, and multicultural organizations.
• Additional language capability.

Culture & Benefits

• Inclusive work environment focused on individual dignity, diversity, and merit.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, recognition awards, and an annual performance-based bonus.