CQ/RA Specialist BeNeLux
Il y a 5 heures
Machelen, Flanders, Belgique
Biopharma Careers
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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 GroupJob Sub Function:Regulatory Product Submissions and RegistrationJob Category:ProfessionalAll 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 Qualit
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 GroupJob Sub Function:Regulatory Product Submissions and RegistrationJob Category:ProfessionalAll 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 Qualit