CQ/RA Specialist BeNeLux

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

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?

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.

• 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

We are looking for someone who combines quality and compliance knowledge with strong collaboration, communication, and organizational skills.

• Bachelor’s degree or equivalent business experience

• Knowledge of Quality Management Systems and/or the healthcare industry is preferred

• 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

• 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

• Fluent English and Dutch or French, both written and spoken, 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

At 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.