CQ/RA Specialist BeNeLux

Johnson & Johnson MedTech; Diegem; Vor Ort; EUR 63.000 - 98.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Zusammenfassung

Johnson & Johnson DePuy Synthes is recruiting a CQ/RA Specialist to join the Benelux Commercial Quality team in Diegem, Belgium. You will help maintain the Quality Management System, support regulatory submissions, and drive compliance across the Belgium and Luxembourg markets.

You will partner with Commercial Quality, quality teams, and local commercial groups to ensure alignment with regulatory expectations and internal standards while coaching teams and advancing continuous improvement

Qualifikationen

• Bachelor's degree or equivalent business experience.
• Knowledge of Quality Management Systems and/or healthcare industry preferred.

Aufgaben

• Supporting QMS and quality activities across Belgium and Luxembourg.
• Managing CAPAs, non-conformances, complaint investigations and recalls.
• Supporting implementation of corporate quality standards and compliance activities.
• Leading internal and supplier audits where applicable.
• Coaching employees on quality topics and requirements.
• Leading change control activities and quality system improvements.
• Maintaining quality documentation and data.
• Creating SOPs for contractor interactions.
• Supporting quality projects and digital tool implementation.
• Participating in quality/regulatory committees and project teams.
• Maintaining quality records and metrics.

Kenntnisse

Quality Assurance

Regulatory Affairs

Auditing

Documentation

Data Integrity

Excel

PowerPoint

Word

Communication

Project Management

AI Awareness

Ausbildung

Bachelor's degree or equivalent

Tools

Microsoft Office

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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

• 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.

Required 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

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.

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