Senior Quality and Compliance Specialist

Johnson & Johnson Co.; Machelen; Hybrid; EUR 76,000 - 96,000; Full time

Benefits offered by this job

Hybrid work model

12-month contract

Job summary

Johnson & Johnson MedTech is seeking a Senior Quality and Compliance Specialist to support the EMEA EP organization from the European HQ in Diegem, Belgium. You will lead CAPA/NCR activities, act as Field Action Coordinator, and support audit readiness and regulatory requests.

The role requires 4–5 years in a regulated medical device environment, knowledge of EU MDR, ERP/QMS experience, and strong English skills. Hybrid work: 3 onsite days, 2 remote days; 12-month contract.

Qualifications

• Bachelor's degree in a scientific field; 4–5 years in regulated medical devices.
• Knowledge of EU MDR 2017/745 and European regulatory environment.
• Experience with CAPA, NCR investigations, root-cause analysis and CAPA closure.
• ERP and electronic QMS experience for CAPA, NCR, audits and training records.
• Experience with Field Actions: Holds, Stop Shipments, recalls.
• English proficiency; additional languages a plus.

Responsibilities

• Lead CAPA and NCR investigations and develop effective solutions.
• Act as Field Action Coordinator for Holds, Stop Shipments, recalls.
• Coordinate audit readiness and support audits; close audit observations.
• Support regulatory and quality compliance activities with Health Authority requests.
• Oversee DC rework activities; ensure procedures are followed.
• Inspect returned products at the Distribution Center as required.
• Collaborate with cross-functional teams to resolve quality issues.
• Participate in local/global projects to improve quality processes.
• Support training and retention documentation for the department.

Skills

CAPA investigations

NCR investigations

Root cause analysis

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in a scientific field

Tools

ERP systems

Electronic QMS

Job description

Senior Quality and Compliance Specialist

Location: Diegem, Belgium, (with travel to the Courcelles site approximately once every three to four weeks).

Work mode: Hybrid working - 3 days onsite, 2 remote days

Duration: 12 months contract

Hours: 40

This role does not accept freelancers

Imagine your next project supporting Quality and Compliance for the EMEA EP organisation at the European HQ in Belgium, developing the next generation of smarter, less invasive, and more personalized medical treatments that profoundly impact health for humanity.

We are searching for the best talent for a Senior Q&C Specialist to be in Diegem, Belgium! This position is based in the European HQ in Belgium. The Senior Q&C Specialist is responsible to support Quality and Compliance of the EMEA EP organisation.

roles and responsibilities

• Lead CAPA and Non-Conformance (NCR) activities, including investigation of process and procedural issues and development of appropriate solutions.
• Act as Field Action Coordinator, supporting the execution of Quality Holds, Stop Shipments, product recalls, and Field Corrective Actions.
• Coordinate audit readiness and execution, support during internal and external audits, and follow-up of audit observations.
• Support regulatory and quality compliance activities, including Health Authority requests.
• Oversee rework activities in the Distribution Center, ensuring activities are performed in accordance with applicable procedures.
• Perform inspections of returned products at the Distribution center, as required.
• Collaborate with cross-functional teams and key stakeholders to resolve quality issues and drive effective and sustainable improvements.
• Participate in local and global projects aimed at improving Quality processes and operational effectiveness across EMEA and the broader organization.
• Support departmental training and record retention compliance.

how to succeed

• Bachelor's degree in a scientific subject area preferred, with 4-5 years of experience in a regulated medical device; alternatively, proven experience in quality systems related to medical devices or other regulated environments
• Knowledge of EU Medical Device Regulation (EU MDR 2017/745) and the European medical-device regulatory environment.
• Experience working with ERP systems and electronic Quality Management Systems for CAPA, Non-Conformance, audit, and document/training management are a strong advantage.
• Practical experience with CAPA and Non-Conformance investigations, including root cause analysis and corrective/preventive actions.
• Experience with Field Actions, including Quality Holds, Stop Shipments, product recalls, and Field Safety Corrective Actions.
• Familiarity with GDP/distribution and traceability requirements for medical devices.
• Experience working in a multinational and cross-functional environment, particularly across different EMEA countries.
• Experience participating in process-improvement or Quality System projects.
• Proficiency in spoken and written English is required; additional language skills are a plus.
• Strong attention to detail, organizational skills, and ability to work both independently and in cross-functional teams.
• Comfortable working in a fast-paced, compliance-driven environment, with a proactive approach to problem-solving and continuous improvement.

This role offers a very competitive hourly rate. This contract will run for 12 months

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means "You Belong".