CQ/RA Specialist BeNeLux

Johnson & Johnson Co.; Diegem; Presencial; EUR 63.000 - 98.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Descripción de la vacante

Johnson & Johnson, DePuy Synthes, is seeking a CQ/RA Specialist in Diegem, Belgium to support the Benelux Commercial Quality team. The role focuses on maintaining QMS, ensuring regulatory compliance, and collaborating with local teams.

You will help implement corporate quality standards and participate in continuous improvement initiatives. The candidate should have a Bachelor’s degree or equivalent experience, strong QA/RA background, and fluency in English with Dutch or French.

Formación

• Bachelor’s degree or equivalent business experience.
• Experience with quality and regulatory requirements in healthcare/MedTech is preferred.
• Fluent English; Dutch or French language skills are required.

Responsabilidades

• Support and maintain 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 staff on quality topics.

Conocimientos

Quality Management Systems

Regulatory Affairs

Communication

Collaboration

Training delivery

Data Integrity

Microsoft Office

Educación

Bachelor’s degree or equivalent business experience

Herramientas

Microsoft Office

Descripción del empleo

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Product Submissions and Registration

Job Category: Professional

Job Posting Locations: Diegem, Flemish Brabant, Belgium

Job Description

DePuy Synthes is recruiting for a CQ/RA Specialist located in Diegem, Belgium. Purpose We 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 for In 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

• Supporting the Quality Management System (QMS) and associated quality activities across Belgium and Luxembourg
• Managing and supporting quality processes including CAPAs, non-conformances, complaint investigations, Field Safety Notices, recalls, document control, and training systems
• Supporting implementation and maintenance of corporate quality standards, procedures, and compliance activities
• Planning and leading internal audits and supporting supplier audits, where applicable
• Coaching and training employees on quality-related topics and requirements
• Leading change control activities and supporting quality system improvements
• Collecting, reviewing, and maintaining quality documentation and supporting data
• Creating and maintaining standard operating procedures related to interactions with contractors
• Supporting quality projects, implementation of new digital tools, and continuous improvement initiatives
• Participating in committees and project teams focused on quality and regulatory compliance topics
• Monitoring and maintaining quality records, project outcomes, and quality metrics in an accurate and timely manner
• Collaborating with local and global Johnson & Johnson departments to support quality and compliance objectives

Qualifications / Requirements

We are looking for someone who combines quality and compliance knowledge with strong collaboration, communication, and organizational skills. Education Bachelor’s degree or equivalent business experience Knowledge of Quality Management Systems and/or the healthcare industry is preferred Experience & Skills Required Previous Quality and/or Regulatory Affairs experience Ability to build effective relationships and collaborate across local and EMEA-based business and quality teams Strong communication, interpersonal, and influencing skills Results-oriented approach with a focus on quality and operational excellence Ability to build trust and credibility with customers, employees, and internal partners Strong self-awareness and adaptability Analytical mindset and process-oriented approach Experience delivering training to employees and teams Strong awareness of Good Documentation Practices and Data Integrity principles Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity Preferred Knowledge of Quality Management Systems, including ISO 13485 Experience working within the healthcare industry Experience working within a mid-sized or multinational organization Internal ISO auditor certification Language Requirements Fluent English and Dutch or French, both written and spoken

What we offer

We 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 inclusion At 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.

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

Benefits

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. *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.