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?

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 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 c...