EMEA Staff Quality Specialist Service & Repair, Orthopedics

Johnson & Johnson Innovation; Amersfoort; On-site; EUR 64,000 - 103,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Job summary

Johnson & Johnson is seeking a Staff Quality Specialist – Service & Repair, Orthopedics to strengthen quality systems for global service centers. You will partner with Service Operations, Customer Quality, and other teams to harmonize processes, drive CAPAs, and ensure consistent quality performance across sites.

The role requires 5+ years in quality within regulated environments, strong communication, and the ability to travel (5–10%).

Qualifications

• Bachelor degree in engineering, scientific or quality disciplines or equivalent industry experience.
• 5+ years in Quality (medical devices and validation of equipment preferred).
• Lean Six Sigma Green/Black Belt and PM certification are assets.

Responsibilities

• Serve as main quality and compliance contact for assigned Worldwide Service Centers in the region.
• Ensure compliant QS procedures at Service Centers including change management strategies.
• Coordinate Regional Quality Plan and oversee QMS execution across sites.

Skills

Quality management

ISO 13485

Analytical thinking

Risk-based decisions

Project management

Lean Six Sigma

Communication skills

English fluency

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in engineering or technical field

Tools

EtQ

Trackwise

Salesforce S&R

Windchill

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world 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 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 humanity. Learn more at jnj.com.

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.

Job Function: Quality

Job Sub Function: Customer/Commercial Quality

Job Category: People Leader

All Job Posting Locations: Amersfoort, Utrecht, Netherlands

Job Description: We are looking for EMEA Staff Quality Specialist Service & Repair, Orthopedics to make a meaningful impact on the quality and reliability of medical device service and repair. As the Staff Quality Engineer – Service Quality, you will serve as a trusted quality and compliance partner for assigned DPS Service Centers, helping teams consistently execute Quality System requirements and deliver dependable outcomes for customers and patients.

In this highly collaborative role, you will work across Service Operations, Customer Quality, and other key functions to strengthen and harmonize service processes, deploy quality agreements and training, and promote consistent practices across assigned sites. You will use data, risk-based thinking, and structured problem-solving to monitor performance, address nonconformances, CAPAs, and audit observations, and identify opportunities for continuous improvement. This is an opportunity to influence quality beyond a single site, lead cross-functional initiatives, and help shape a compliant, efficient, and continuously improving global Service & Repair network.

DUTIES & RESPONSIBILITIES

• Be the main point of contact for quality and compliance aspects for assigned WW Service Center(s) in the assigned Region
• Ensure general compliance support for consistent and correct execution of QS procedures at all Service Centers e.g. change management strategies
• Coordinate the Regional Quality Plan and provide regional oversight of QMS execution and identify systemic compliance gaps across sites.
• Be the subject matter expert for the validation of equipment and computer system validation of equipment
• Ensure qualification and management of Suppliers related to Installation & Servicing
• Collaborate with Service Operations and Field Service to ensure global harmonization of service processes.
• Collaborate with Customer Quality representatives to ensure compliance with reporting requirements of all Service centers and accuracy of service evaluations linked to customer complaints
• Support tracking of monthly performance and quality metrics for each Service Center and attend the monthly/annual review meetings
• Coordinate and support resolution for all nonconformances, CAPAs and audit observations related to Installation and Servicing for the Netherlands Service Center and regional QMS
• Collaborate on shared/global procedures update and harmonization
• Support Service Sites internal and external audits based on sites requirements
• Conduct training related to procedural changes and coordinate with relevant stakeholders to investigate and document deviations identified at the sites.
• Manage the initiation and review of Service Level Agreements
• Responsible for communicating business related issues or opportunities to the next management level
• Conduct data driven analysis based on requirements
• Lead continuous improvement initiatives to ensure efficiency, effectiveness, and compliance
• Maintain awareness of ISO standards while developing solutions to satisfy business needs
• Performs other duties assigned as needed.
  

Required Qualification and Core Competencies for the role:

• Bachelor degree in engineering, scientific or quality and compliance disciplines. Will accept the equivalent relevant industry experience in the absence of a degree
• At least 5 years experience in Quality (medical devices and validation of equipment preferred)
• Recommended Lean six sigma Green/Black belt, Project Management Certification will be an asset for this position
• Experience in regulated ISO 13485 industries
• Excellent communications skills
• Organizational skills, ability to resolve conflicts
• Strong analytical thinking skills and the ability to work in a flexible way under time pressure in local and global teams
• Ability to make risk based decisions under time pressure
• Understands the business implications regarding quality positions and decisions
• High sense of responsibility and reliability
• Work independently within established timelines
• Experience with ETQ, Windchill and Saleforce S&R system will be beneficial
• Fluent in English
• Ability to travel if and when required (5%-10%)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

EXPERIENCE AND EDUCATION

• Bachelors degree in engineering or other technical field preferred.
• Experience in Medical Device environment (2-5 years).
• Recommended Lean six sigma Green/Black Belt, Project Management Certification or ASQ certification (CIA, CQE) are an asset for this position.
• Experience in regulated ISO 13485 industries.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Excellent communications and analytical skills are required.
• Ability to work in a team is required.
• Organizational skills, ability to resolve conflicts.
• Analytical/Problem solving skills.
• High sense of responsibility and reliability.
• Work independently within established timelines.
• Experience with EtQ, Trackwise, and Salesforce are beneficial for this role.
• Additional language skills are beneficial for this role.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Required Skills: Business Savvy, Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management

The anticipated base pay range for this position is: €64 000,00 - €103 040,00

Benefits: In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.