EMEA Quality Lead - Service & Repair (Orthopedics)

Johnson Johnson; Amersfoort; On-site; EUR 70,000 - 110,000; Full time

Job summary

Johnson & Johnson in the Netherlands is seeking an experienced Staff Quality Specialist Service & Repair, Orthopedics to boost quality and reliability across our global Service & Repair network. You will partner with Service Operations, Customer Quality and other functions to harmonize processes, deploy quality agreements, train staff, handle CAPAs and audits, and drive data‑driven improvements.

Required: Bachelor degree in engineering or quality, 5+ years in quality for medical devices, ISO

Qualifications

• Bachelor degree in engineering or quality disciplines (or equivalent experience).
• Minimum 5 years in Quality (medical devices and equipment validation preferred).
• Lean six sigma Green/Black belt; PM certification an asset.
• Experience in regulated ISO 13485 industries.
• Excellent communications skills.
• Organisational skills; ability to resolve conflicts.
• Strong analytical thinking; work under time pressure in global teams.
• Ability to make risk-based decisions under time pressure.
• Understands business implications of quality decisions.
• Reliable with high sense of responsibility.
• Ability to work independently within established timelines.
• Experience with ETQ.

Responsibilities

• Be main contact for quality and compliance for assigned Service Centers worldwide.
• Ensure QS procedures and change management are consistently executed.
• Coordinate Regional Quality Plan and oversee QMS execution.
• Validate equipment and computer system validation.
• Qualify and manage Suppliers for Installation & Servicing.
• Collaborate to harmonize service processes globally.
• Support reporting requirements and quality metrics for centers.
• Monitor CAPAs, nonconformances and audit observations.
• Coordinate audits and train on procedural changes.

Skills

Quality management

Regulated industry

Analytical thinking

Risk-based decisions

Communication skills

Project management

Education

Bachelor degree in engineering/quality

Tools

ETQ

ISO 13485

Job description

Johnson & Johnson in the Netherlands is seeking an experienced Staff Quality Specialist Service & Repair, Orthopedics to boost quality and reliability across our global Service & Repair network. You will partner with Service Operations, Customer Quality and other functions to harmonize processes, deploy quality agreements, train staff, handle CAPAs and audits, and drive data‑driven improvements.

Required: Bachelor degree in engineering or quality, 5+ years in quality for medical devices, ISO