The QA/RA Manager leads and manages all Quality Assurance and Regulatory Affairs activities, ensuring that our Quality Management System remains fully compliant with international medical device regulations, including ISO 13485, EU MDR. This role is essential in supporting our position as a trusted supplier of raw materials (monofilaments) to medical device manufacturers.

Key Responsibilities:

Quality Assurance

• Develop, implement, and maintain the Quality Management System in accordance with ISO 13485.
• Prepare management review
• Lead internal and external audits (e.g., Notified Body, customer, supplier,…) and ensure timely closure of findings.
• Manage Document Control, supplier QAA, CAPA, Change Control, Non-Conformities, Complaint Handling, and Supplier Quality processes, including validations.
• Monitor and continuously improve quality metrics, ensuring robust root cause analysis and effective corrective and preventive actions.
• Provide QA oversight on manufacturing, and post-market activities.
• Train internal teams on QMS procedures, regulatory requirements, and best practices.
• Promote GMP activities in non-QC area’s.
• Collaborate with cross-functional teams including R&D, Production, and Sales to embed a culture of quality throughout the organization.

Regulatory Affairs

• Collect and prepare technical documentation, support regulatory filings, and product registrations for our customers.
• Maintain up-to-date knowledge of international regulatory developments and assess their impact on product safety and performance
• Monitor EU MD Regulation, and other applicable standards and regulations.
• Serve as the primary contact with regulatory bodies and Notified Bodies.
• Ensure compliant labeling, advertising, and promotional materials.

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Quality Management, or related field.
• Minimum of 10 years of experience in Quality Assurance and/or Regulatory Affairs, within the medical device or pharmaceutical sector.
• Demonstrated experience in managing ISO 13485 QMS, GMP processes and basic understanding of regulatory processes.
• Experience in Class II - III medical devices is preferred.
• Proven track record of successfully managing audits and regulatory inspections.
• In-depth understanding of global medical device regulations (ISO 13485, MDR, etc.).
• Strong leadership, communication, and problem-solving skills.
• High level of accuracy, attention to detail, and analytical thinking.
• Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Proficient in QMS software (BizzMine), Microsoft Office Suite, and documentation tools.
• Fluent in Dutch and English, both verbal and written.

Luxilon, a family-owned company founded in 1959, specializes in the development and production of high-tech synthetic fibers for industrial, medical, and sports applications. In addition to being globally recognized as the reference in tennis strings, our medical division has also been a global player since the early 1980s in providing innovative solutions that contribute to healthcare through high-quality medical fibers and materials. Our daily focus on innovation and quality control results in state-of-the-art products and exceptional customer service.

To further expand our team in Wijnegem, we are looking for a QA/RA Manager (m/f/x).

• A challenging and versatile QA role within an innovative and high-tech company.
• Plenty of autonomy and responsibility.
• A hands-on position with significant impact.
• A family-oriented and personal working atmosphere in a team of experts.
• An attractive salary + company car + additional benefits.
• A 40-hour workweek with 12 additional off-days (ADV), collective holidays between Christmas and New Year and during the construction industry holiday in July.

This procedure was exclusively entrusted to Winsearch, therefore it isn’t appreciated that others directly approach our customer with candidates 

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