Senior Quality Systems Manager - Medtech - EMEA

• Leading the Quality Assurance team for the EMEA region - based in Brussels
• Right hand to the Head of Regulatory & Quality Systems
• Process optimization & improvement - strategic development

• Support the International organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality
• Lead and manage Quality Systems activities including audit readiness.
• Lead and manage specifically the Document Management, Record Management, Training Management, CAPA, QNC, Field Action, and Supplier Quality Management quality systems in the region.
• Provide strategic and tactical vision and consultation toward the quality system development and implementation.
• Provide strategic and executive support to ensure alignment within the International Organization.
• Manage communications with the organization's Certification Body regarding all quality systems related activities and issues, including planning and responding to audits.
• Develop objectives and key performance indicators and tenaciously pursue
• Maintain state of the art knowledge in the quality related fields
• Leads the implementation, maintenance and training for relevant quality systems and tools, compliant to internal and external requirements, to meet business needs.
• Respond to customer needs in an accurate and timely fashion

• Provide leadership for quality system development, and ongoing process improvements.
• Initiate, develop and implement new quality concepts, tools and strategies to improve business systems, practices, and assure business objectives are met.
• Communicate project strategy and status to superiors and peers in a way that is timely, concise, accurate and responsive.
• Work in close cooperation with the Regulatory team.

• At least a Bachelor's degree in a science, business, engineering, or related
• At least 10 years of related experience in the medical device or pharmaceutical industry managing quality systems.
• Analytical & detail oriented, team player.
• Excellent communication, problem solving and management skills are required.
• Proven Experience with CAPA, Change Management, Supplier Quality Assurance, and Risk Management is required.
• Position requires strong knowledge of MDD 93/42/EEC / MDR 2017/745, ISO 9001, and ISO 13485 requirements
• Ideally knowledge also on FDA, cGMP
• Experience in MS Office and Teams
• Excellent verbal and written English communication

• Experience with managing CE-marking and EU Regulatory Affairs

• A complete and attractive salary package in line with your experience (Base salary, Bonus, Company Car, Net allowances, Insurances, etc.)
• The chance to join a market leader with high people value
• Join a company that values and offers multiple career opportunity locally & globally

Michael Page