Sr. QA/ra Officer

At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates._

**Company Info**
- At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates. We employ 25.000 people globally, 1500 people in EMEA, and have our EMEA HQ in Leuven, Belgium. In Netherlands we have an office in Deventer;_

**Department Info**
- In The Netherlands, after the integration of Quirem Medical in the Terumo Group in 2019, we have over 50 associates. Over 40 of us work in our site in Deventer, dedicated to the _**_Therapeutic Interventional Oncology _**_(TIO) product portfolio (Production, R&D, Clinical & Medical, QA, RA, Supply Chain and Support Services). In addition, we have several colleagues in sales, representing all Terumo products in The Netherlands as part of the Benelux sales organisation_

**Responsibilities**:

- Supporting QA&RA manager in driving Quality & Regulatory compliance while aligning overall organization to meet business needs & objectives
- Maintaining Technical dossiers - including preparing necessary documentation - for all Quirem Medical's products
- Monitoring regulatory developments and assessing business impact with the Function Requirements: (education, experience, competences, etc.)
- Leading/supporting initiatives to improve the quality and manufacturing efficiency of Quirem products.

**Profile Description**
- BSc/MSc degree or higher in science, engineering, medicine or a related field with 1+ years of relevant experience in medical device or 4+ years in pharma/biotechnology in a QA&RA function.
- Knowledge of medical devices regulatory frameworks including MDR, AIMDD, MDD and standards like the ISO 13485:2016 as well as other applicable global regulatory frameworks and standards.
- Familiar with Medical Devices Software product development and technical dossiers.
- Knowledge of medical device software standards like 1EC62304.
- Project management experience.
- Working in multidisciplinary and international teams.
- Ability to work with different software packages and a document management system.
- Excellent interpersonal skills and communication skills, written and oral, in English. Dutch is a plus.
- Motivated and accurate.
- Striving for optimal quality in own work and that of others.
- Demonstrates ownership and curiosity and continuously looking for improvement without losing practicality out of sight.
- Likes organizing and providing structure. Flexible whenever the 'dynamics' of the job ask for it.

**Offer**

We offer a very challenging role within this pioneering division of Terumo. You play an active role to launch our products on a global level, and as such give patients access to our technology to improve the quality of their lives.

You can count on a competitive salary and extra benefits, coaching by your manager and colleagues, and access to a vast amount of training content to develop yourself in a professional way.

**Interested?**
- Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region._