CQ/RA Specialist BeNeLux

Biopharma Careers; Diegem; Hybrid; EUR 63,000 - 98,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

Johnson & Johnson in Diegem, Belgium is seeking a CQ/RA Specialist to support the Benelux Commercial Quality team. The role focuses on maintaining the QMS for MedTech in Belgium and Luxembourg, ensuring compliance with regulatory expectations, and collaborating with local and regional partners.

You will lead CAPAs, audits, and documentation efforts while coaching teams on quality requirements. This position is hybrid and offers a comprehensive benefits package.

Qualifications

• Bachelor’s degree or equivalent business experience.
• Knowledge of Quality Management Systems and/or the healthcare industry is preferred.
• Experience & skills: collaboration, communication, and regulatory understanding.

Responsibilities

• Support the Quality Management System (QMS) across Belgium and Luxembourg.
• Manage CAPAs, non-conformances, complaint investigations, Field Safety Notices, recalls, document control, and training systems.
• Lead internal audits and support supplier audits.
• Coach and train employees on quality-related topics and requirements.
• Lead change control activities and quality system improvements.
• Monitor and maintain quality records, project outcomes, and quality metrics.

Skills

Analytical reasoning

Regulatory affairs

Quality assurance

Project management

Data integrity

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Job description

Johnson & JohnsonPosted October 21, 2026# CQ/RA Specialist BeNeLuxDiegem, Belgium Full timeRegulatory AffairsNotify me about similar jobsView Full Job & Apply at Johnson & JohnsonJohnson & Johnson is the source of truth for this posting and owns the application process. We surface normalized context and market comparison you won't find on the original listing.## About this opportunityAt 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:**Regulatory Affairs Group**Job Sub Function:**Regulatory Product Submissions and Registration**Job Category:**Professional**All Job Posting Locations:**Diegem, Flemish Brabant, Belgium**Job Description:**DePuy Synthes is recruiting for a **CQ/RA Specialist** located in Diegem, Belgium.PurposeWe are looking for a CQ/RA Specialist to join the Benelux Commercial Quality team at DePuy Synthes.In this role, you will support and maintain the Quality Management System (QMS) for the MedTech businesses in Belgium and Luxembourg. Working closely with the Commercial Quality Manager, Commercial Quality colleagues across the Benelux region, and local commercial teams, you will help ensure compliance with applicable quality requirements, company standards, and regulatory expectations.Are you interested in helping strengthen quality and compliance while working across commercial, quality, and healthcare environments?You will be responsible forIn this role, you will contribute to the effective operation of the Quality Management System and support quality activities across Belgium and Luxembourg. You will work closely with local and regional partners to help ensure quality processes are executed consistently and in accordance with company and regulatory requirements.Key responsibilities include:Supporting the Quality Management System (QMS) and associated quality activities across Belgium and LuxembourgManaging and supporting quality processes including CAPAs, non-conformances, complaint investigations, Field Safety Notices, recalls, document control, and training systemsSupporting implementation and maintenance of corporate quality standards, procedures, and compliance activitiesPlanning and leading internal audits and supporting supplier audits, where applicableCoaching and training employees on quality-related topics and requirementsLeading change control activities and supporting quality system improvementsCollecting, reviewing, and maintaining quality documentation and supporting dataCreating and maintaining standard operating procedures related to interactions with contractorsSupporting quality projects, implementation of new digital tools, and continuous improvement initiativesParticipating in committees and project teams focused on quality and regulatory compliance topicsMonitoring and maintaining quality records, project outcomes, and quality metrics in an accurate and timely mannerCollaborating with local and global Johnson & Johnson departments to support quality and compliance objectivesQualifications / RequirementsWe are looking for someone who combines quality and compliance knowledge with strong collaboration, communication, and organizational skills.EducationBachelor’s degree or equivalent business experienceKnowledge of Quality Management Systems and/or the healthcare industry is preferredExperience & SkillsRequiredPrevious Quality and/or Regulatory Affairs experienceAbility to build effective relationships and collaborate across local and EMEA-based business and quality teamsStrong communication, interpersonal, and influencing skillsResults-oriented approach with a focus on quality and operational excellenceAbility to build trust and credibility with customers, employees, and internal partnersStrong self-awareness and adaptabilityAnalytical mindset and process-oriented approachExperience delivering training to employees and teamsStrong awareness of Good Documentation Practices and Data Integrity principlesProficiency with Microsoft Office applications, including Excel, Word, and PowerPointDemonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivityPreferredKnowledge of Quality Management Systems, including ISO 13485Experience working within the healthcare industryExperience working within a mid-sized or multinational organizationInternal ISO auditor certificationLanguage RequirementsFluent English and Dutch or French, both written and spokenWhat we offerWe offer a collaborative environment where learning, innovation, and professional development are encouraged.In this role, you will have the opportunity to work across quality, regulatory, and commercial functions while supporting products and solutions that help improve patient outcomes.Our commitment to inclusionAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.#LI-Hybrid#DePuySynthesCareers**Required Skills:****Preferred Skills:**Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented**The anticipated base pay range for this position is:**€63 300,00 - €97 635,00**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.