Duties/Responsibilities:
- Maintain, implement and improve the Quality Management System (QMS) according to ISO 13485
- Manage the implementation of a single Belux QMS according to ISO 13485
- Be process oriented, and able to issue processes, policies and work instructions.
- Monitor the QMS : KPI (Quality objectives and other indicators), complaints, supplier evaluation, CAPA, audits (internal, and if needed, external)) …
- Question the status quo and manage improvement actions with stakeholders
- Raise awareness and train colleagues on QA/RA conscious mindset
- Assure compliance with applicable legislation related to organization’s activities (MDR, IVDR, Biocides, …)
- Manage the quality mailboxes and ensure appropriate follow-up
- Implement and manage the product library and the QMS processes
- Assist in translating the business strategy into operational processes, taking into account all regulations and stakeholders (e.g. new distribution, update ISO standards, etc.)
- Manage and implement updates of regulation updates
- Optimize all processes in collaboration with the other departments
You will be part of and supported by the Quality/Regulatory Team.
Skills:
- Be a strong assertive communicator with diplomacy
- Have a pro-active mindset
- Take initiative
- Be pragmatic and efficient
- Be customer-oriented, independent, analytical, stress-resistant, flexible, organized
- Teamplayer
- Take Ownership for managing tasks
- Be motivated
- Experience with ISO 13485, ERP, …
- Good knowledge of Microsoft Office (Word, Excel, Outlook, etc.)
- Knowledge of medical device legislation (MDR) is an added advantage
- Trilingual Dutch / French / English (spoken and written)
Our offer:
- Part of a young and dynamic RAQA team
- Training as required (product, ERP, ..) : both internal and external
- A job with a lot of variety of tasks and interaction within the BeLux structure as well as with the other Duomed affiliates
- Possibility to learn and develop your skills
- Very open atmosphere with room for initiative
- A challenging environment where wellbeing and results go hand in hand.
- We offer you an open-ended contract (after a possible interim period), supplemented with fringe benefits such as meal vouchers, AG group insurance (pension, death & guaranteed income), DKV hospitalization insurance, purchasing power premium and eco-cheques within Joint Committee 200.
- Room for initiative, in a company with an excellent reputation in the medical world.