Position: Quality Engineer for Regulatory Team
Company: Materialise
Category: Other
Experience required: 1y
English level: upper
Published: 2021-06-01T00:00:00+03:00

The Materialise Medical Device portfolio, which exists of 3D personalized solutions (both 3D printed and software), is brought to the market by a global virtual tight-knit team.

Acting as specialists, each and every team-member contributes to shaping the regulatory landscape and concepts of Materialise’s worldwide presence. This includes regulations of the EU, MDSAP jurisdictions and selected other markets.

To help maintain the Quality Management System for Regulatory activities, **we are looking for a Quality Engineer.** This person is responsible to empower the RA-team (Belgium, Brazil, France, UK, Ukraine) and internal business stakeholders to facilitate swift market access for our innovative products.

The Quality Engineer is responsible for improvement initiatives and projects, which are subject to day-to-day management oversight by the Global Quality and Regulatory Manager (US-based), the Quality Management Representative (EU, Belgium) and Regulatory Affairs Manager (EU, Belgium).

**Responsibilities:**

- Further build global Quality Management System for Regulatory Affairs team in line with MDSAP - Medical Device Single Audit Program (international), MDR - Medical Device Regulation (Europe), i.e. global regulatory framework, (ISO) standards.
e.g. Will maintain the SOPs that are used for assessment of the change, maintenance of technical documentation, release of products.

- Act as the product owner for the SharePoint online portals for the global regulatory affairs team and manage projects related to these portals.
- Align with Quality manager of HQ and global Quality and Regulatory Manager regarding quality objectives and quality initiatives.

**Required:**

- Experience in quality operations in a regulated environment, such as a medical device, pharmaceutical, automotive/aviation company, etc.

- Broad interest in different domains of the lifecycle of a medical device (interest for the fields of team members in order to provide regulatory support to new device development, change in services/production environment, formulate requirements that will be added to the template).

- Affinity with end-to-end process view thinking / systematic approach – all activities of this expert need to be focused on RA specialists and labeling team members working in a more and more systematic way.

- Affinity with writing documentation, such as SOPs (processes) in English. Therefore, **fluency in English - written and spoken.**

- Communication experience with stakeholders in a global matrix structure.

- Meta-data/website architecture mindset, when it comes to building the SharePoint portal.

**Education:**

Academic degree in the domain of Engineering, Law, Pharmaceutical, Biomedical.

**Career opportunities:**

Possibility to grow into a Regulatory Affairs or a Quality function within Materialise.