To strengthen and become part of our RA & QA department we announce the following vacancy in the European Head Office in Zoetermeer, the Netherlands
Quality Assurance Manager
The QA manager, reporting to the head of Regulatory and Quality department, will closely work with management, subsidiaries and other sales channels to ensure company’s compliance with medical device regulations, international standards on quality assurance, company’s quality management system and other applicable statutory requirements.
Responsibilities and Tasks
- Proactively maintain, manage and improve company’s group ISO 13485/9001 certified quality management system (QMS);
- Ensure that company’s group QMS complies at all times with company’s quality assurance policy and applicable standards and statutory requirements, including but not limited to ISO 13485 and medical device regulations;
- Oversee subsidiaries’ and distributors’ compliance with company’s quality assurance policy and QMS requirements as well as with other applicable standards and requirements;
- Regularly collaborate with company’s global headquarters in Japan on quality assurance and regulatory matters; implement relevant processes and other requirements;
- Own and manage the QMS databases;
- Manage and be responsible for the Certification Body audits and internal audits; evaluate the results, define and monitor the implementation of the necessary actions;
- Manage QMS required activities such as management review meetings, quality objectives, QMS status overviews for management and other staff, QMS reports, etc.;
Skills and Competences
- HBO-level education in a relevant field;
- 5-10 years of work experience in the role of quality engineer or quality assurance manager in the medical device industry;
- Strong knowledge of ISO 13485 and ISO 9001; relevant education preferred;
- Knowledge of ISO 14001, OHAS 18001 and ISO 27001 quality systems;
- Strong knowledge of the EU Medical Device Directive and other regulations, standards (e.g. IEC 60601-1 series) and guidelines applicable on medical devices;
- Strong knowledge of and experience with risk management;
- Fluent in English verbal as well as written; fluency in Dutch is preferable;
In a company with over 1.000 employees, we are always looking for skilled and motivated colleagues to help us further enhance our business.
We welcome your application.
Pim Vogel, Senior Manager HR Europe. E-mail: email@example.com