Senior Quality and Compliance Specialist

h3Senior Quality and Compliance Specialist /h3 h3Location: Diegem, Belgium, (with travel to the Courcelles site approximately once every three to four weeks). /h3 h3Work mode: Hybrid working
- 3 days onsite, 2 remote days /h3 h3Duration: 12 months contract /h3 h3Hours: 40 /h3 h3This role does not accept freelancers /h3 pImagine 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. /p pWe are searching for the best talent for a Senior QC Specialist to be in Diegem, Belgium This position is based in the European HQ in Belgium. The Senior QC Specialist is responsible to support Quality and Compliance of the EMEA EP organisation. /p h3roles and responsibilities /h3 ul liLead CAPA and Non-Conformance (NCR) activities, including investigation of process and procedural issues and development of appropriate solutions. /li liAct as Field Action Coordinator, supporting the execution of Quality Holds, Stop Shipments, product recalls, and Field Corrective Actions. /li liCoordinate audit readiness and execution, support during internal and external audits, and follow-up of audit observations. /li liSupport regulatory and quality compliance activities, including Health Authority requests. /li liOversee rework activities in the Distribution Center, ensuring activities are performed in accordance with applicable procedures. /li liPerform inspections of returned products at the Distribution center, as required. /li liCollaborate with cross-functional teams and key stakeholders to resolve quality issues and drive effective and sustainable improvements. /li liParticipate in local and global projects aimed at improving Quality processes and operational effectiveness across EMEA and the broader organization. /li liSupport departmental training and record retention compliance. /li /ul h3how to succeed /h3 ul liBachelor'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 /li liKnowledge of EU Medical Device Regulation (EU MDR 2017/745) and the European medical-device regulatory environment. /li liExperience working with ERP systems and electronic Quality Management Systems for CAPA, Non-Conformance, audit, and document/training management are a strong advantage. /li liPractical experience with CAPA and Non-Conformance investigations, including root cause analysis and corrective/preventive actions. /li liExperience with Field Actions, including Quality Holds, Stop Shipments, product recalls, and Field Safety Corrective Actions. /li liFamiliarity with GDP/distribution and traceability requirements for medical devices. /li liExperience working in a multinational and cross-functional environment, particularly across different EMEA countries. /li liExperience participating in process-improvement or Quality System projects. /li liProficiency in spoken and written English is required; additional language skills are a plus. /li liStrong attention to detail, organizational skills, and ability to work both independently and in cross-functional teams. /li liComfortable working in a fast-paced, compliance-driven environment, with a proactive approach to problem-solving and continuous improvement. /li /ul pThis role offers a very competitive hourly rate. This contract will run for 12 months /p h3you are welcome here /h3 pJohnson 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. /p h3about Johnson Johnson MedTech /h3 pAt 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. /p h3Diversity, Equity Inclusion /h3 pFor 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 inc