Senior Quality Systems Manager

il y a 3 semaines


Brussels, Belgique Michael Page Temps plein

As the Successful Sr Quality System Manager - Medtech - you will have the following responsibilities:

  • 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.

As the Successful Sr Quality System Manager - Medtech - you will have the following requirements:

  • 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

As the Successful Sr Quality System Manager - Medtech - you will have:

  • 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

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