Senior Quality and Compliance Specialist
Bronjnj.talent-pool.com (externe link)Senior Quality and Compliance Specialist voor J&J EMEA, hybride Diegem (België), 40u/week, 12 maanden.
- Locatie
- Diegem, BE
- Werkvorm
- hybride
- Uren
- 40 uur per week
Bekijk bij jnj.talent-pool.com (opent in een nieuw tabblad)
Mail mij vergelijkbare opdrachtenZonder CV of account
Je zoekfiltersquality and compliance specialist · Alle contractvormen
Elke ochtend een e-mail als er nieuwe opdrachten zijn die passen bij je zoekfilters.
Eisen
- Familiarity with GDP/distribution and traceability requirements for medical devices
- Experience with Field Actions, including Quality Holds, Stop Shipments, product recalls, and Field Safety Corrective Actions
- Knowledge of EU Medical Device Regulation (EU MDR 2017/745) and the European medical-device regulatory environment
- Practical experience with CAPA and Non-Conformance investigations, including root cause analysis and corrective/preventive actions
- Strong attention to detail, organizational skills, and ability to work both independently and in cross-functional teams
- Experience working in a multinational and cross-functional environment, particularly across different EMEA countries
- Experience participating in process-improvement or Quality System projects
- Comfortable working in a fast-paced, compliance-driven environment, with a proactive approach to problem-solving and continuous improvement
- Proficiency in spoken and written English
Wensen
- Additional language skills
- Bachelor’s degree in a scientific subject area, 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
- Experience working with ERP systems and electronic Quality Management Systems for CAPA, Non-Conformance, audit, and document/training management
Volledige omschrijving
Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson. 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.
Benefits: This role offers a very competitive hourly rate. This contract will run for 12 months.
Bekijk bij jnj.talent-pool.com (opent in een nieuw tabblad)
Je CV en reacties
Voeg een CV toe om de eisen naast jouw ervaring te bekijken.
Heb je zelf bij de bron gereageerd? Leg dat hieronder vast.
Bewaar de broker en datum in Mijn reacties.