Senior Quality Systems Manager - Medtech - EMEA > Michael Page > Joboolo BE :
Company : Michael Page Location : Brussels Brussels From : Talent BE
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 qualitysystems related activities and issues, including planning and responding to audits.Develop objectives and key performance indicators and tenaciously pursueMaintain state of the art knowledge in the quality related fieldsLeads the implementation, maintenance and training for relevant qualitysystems and tools, compliant to internal and external requirements, to meet business needs.Respond to customer needs in an accurate and timely fashionProvide 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 qualitysystems.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 requirementsIdeally knowledge also on FDA, cGMPExperience in MS Office and TeamsExcellent verbal and written English communicationExperience with managing CE-marking and EU Regulatory AffairsAs 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 valueJoin a company that values and offers multiple career opportunity locally & globally MichaelPage BrusselsBrussels
