Senior Quality Assurance Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Utrecht Netherlands.
They are a global leader in the production of life enhancing Medical Devices. They believe in caring for and finding the brightest specialists around in order to deliver quality, innovation and value and be able to give the best care their products can give and saving lives all over the world.
ROLE DESCRIPTION
As the new Senior QA Manager you will lead a team of QA professionals at the HQ of the company. Your job will be to make sure all device import and distribution activities are compliant to EMEA regulatory and corporate requirements. You will deal with Quality Systems, Audits, Customer complaints, Quality improvement and preservation, CAPA and Deviation, documentation and more. You will be the regional business unit and the single point of contact as the European Representative. The Senior QA manger will be responsible for communicating and interacting with competent authorities concerning all products the company produces and distributes.
RESPONSIBILITIES
• Ensuring the QMS is effective and compliant to all requirements and aligned to the business QMS while being routinely reviewed
• Maintaining all appropriate licences and certifications
• Act as representative within management for ISO 13485
• Setting the short-term and long-term strategy with your team to ensure targets and regulatory compliance are achieved
• Keep technical files documented and up-to-date ready and available for the European Competent Authorities
REQUIREMENTS
• Proven experience and knowledge of managing skills within the Quality Assurance
• 10 years experience within QA in Medical Devices or related to:
o Certifications and requirements of ISO 13485
o MDD/93/42 EEC as amended, CFR Part 820, MEDDEV2.12, GHTF Guidance
o European Authorized Representative
o People motivation and development, effective personnel management
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
