Head of QA & RA

The organisation

Your new company is based in Almere and they are specialized in R&D, manufacturing and commercialization implantable or injectable medical devices. The core focus is on medical devices that are used by physicians to contribute to the quality of life and well-being of patients.

The position

In your new role as the Head of the Regulatory Affairs and Quality Assurance, you will lead and manage the strategic and operational performance of the QA and RA team whilst also focusing on growing the production volumes and meeting the business goals. It is your responsibility to ensure the efficient and effective day-to-day running of the QA and RA department. The focus will be on Quality Assurance, as there are 6 people in the QA team and 2 people in the RA team that will report to you. You will establish and maintain a strong and complaint QMS to meet all the regulatory requirements such as ISO13485, BGMP, MDD, MDR and MDSAP. This will be a big part of the role. Being in the lead in the preparations for audits and regulatory inspections, as well as being responsible for overseeing the GxP training for the company will be a part of your new role as well. Last but not least, you are going to be a member of the Medical Senior Management Team.

Candidate profile

We’re looking for someone with a BSc, MSc or PhD in a scientific area. It is important to have extensive experience of the design and management of Quality Management Systems, as well as having experience with Management Representative responsibilities for at least 3 years. Being a Qualified Lead Auditor to ISO13485 and being capable to conduct internal and supplier audits are a big plus. You need to have experience in managing and developing a high performance team, preferably in QA or RA, as well. Having an understanding of regulations and guidelines of Europe are a must and for this role it is important to have a broad knowledge of ISO (13485) and Good Manufacturing Practices. Excellent English in both writing and speaking are of great importance for this role. In summary, this is a nice and challenging job for an experiences QA Manager with QMS experience and some basic RA knowledge!

Interested?

You can apply to this position by using the link below.