QA/RA Specialist

1. Quality Management System – day-to-day operation

• Manage CAPAs (corrective actions and preventive actions) from start to finish: opening, root cause analysis, action plans, effectiveness checks and closure.
• Record, investigate and follow up non-conformities (product, process, supplier), including disposition decisions.
• Handle user complaints together with the sales and technical teams: registration, investigation, customer response and trend analysis.
• Manage document and change control: draft, review and update procedures, forms and records.
• Follow up supplier qualification and monitoring (evaluations, quality agreements, supplier non-conformities).
• Review production records and support product release.
• Monitor quality indicators (KPIs) and prepare the inputs for the management review.
• Coordinate QMS training and keep training records up to date.

2. Audits & continuous improvement

• Plan and perform internal audits and follow up the resulting actions.
• Prepare and support external audits (certification body, Notified Body, competent authority) and handle the findings.
• Promote a quality culture: train and support colleagues (R&D, production, sales) on QMS requirements.
• Propose improvements to keep the QMS efficient, pragmatic and adapted to a growing company.

3. Regulatory affairs

• Perform the regulatory watch: monitor changes in regulations, MDCG guidance and standards, assess their impact and follow up their implementation.
• Contribute to post-market surveillance (data collection, trend analysis, PMS reports) and vigilance (serious incidents, FSCA).
• Help keep the technical documentation and risk management file up to date
• Support distributors and registrations in new markets on QA/RA topics.

Profile

Background:

• University degree (Master’s preferred) in engineering, biomedical sciences, pharmacy or another relevant scientific discipline.
• 1 to 2 years of experience in quality and/or regulatory affairs for medical devices.
• Hands-on knowledge of ISO 13485:2016 and EU MDR 2017/745; knowledge of ISO 14971 (risk management) is an asset.
• Practical experience with CAPA, non-conformity and complaint handling. Internal auditor training (ISO 13485 / ISO 19011) is an asset.
• Fluent in English and French (written and spoken).
• Experience in a start-up / SME environment or with an QMS tool is an asset.

Soft skills:

• Autonomous, well organized and proactive
• Rigorous, with strong attention to detail
• Pragmatic, solution oriented and a finisher
• Team player and clear communicator with all departments
• Integrity and sense of responsibility

Practical information

Gosselies