CQ/RA Specialist BeNeLux

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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.

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?

Key Responsibilities Include

• 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

Required

Experience & Skills

• 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