QA/ra Officer

Cablon Medical B.V., based in Leusden, The Netherlands, is a supplier of high-quality medical devices, medicines and consumables. In addition, Cablon Medical develops innovative software and hardware for radiotherapy and ultrasound image quality control. These products are sold both in Europe and increasingly International. The corporate culture can be described as Solution
- and People-oriented. Our goal is to contribute to more efficient and effective care in which the patient and healthcare professional are key.

Our QA & RA department is looking for a QA & RA Officer to join the team

**QA/RA Officer (32-40 hr)**

We are looking for an energetic, pragmatic, positive and hands-on individual with high integrity and willingness to learn and grow in the QA & RA domain. Would you like to work in a down to earth professional environment, where the lines of communication are short and you are able to actively contribute to Cablon Medical’s mission and vision? Then this might be the job for you

You will be working in a small QA & RA team and will provide QA & RA support with several Quality Assurance and Regulatory Affairs tasks and processes which are key for the continuous compliance of the Quality Management System (QMS) as well as compliance with all applicable standards, guidelines and regulations for the medical devices developed and manufactured by Cablon Medical. Overall, as a QA & RA Officer in the Medical Device industry, you play a critical role in ensuring that products meet regulatory standards and are brought to market in a compliant and timely manner.

**Your Key Activities**:

- Works together with all departments within the Cablon Medical organization in ensuring that new
- or changed processes / devices meet the applicable regulatory requirements.
- Attention to detail and comfortable reviewing and documenting technical information.
- Maintains technical documentation as required by relevant legislation and oversees the preparation, review, and submission of regulatory documentation. Ensure accuracy, completeness, and timelines of these submissions.
- Implements, monitors and optimizes the quality processes and assists the Process owners with measuring and improving their processes for (departmental) objectives.
- Maintaining and further structuring (processes in) the ERP system (AFAS InSite / AFAS Profit)
- and product license maintenance for regulatory authorities.
- Participate and provide support during External Quality audits and perform Internal Audits.

**Desired Skills and Experience(s)**:

- HBO+, or HBO+ mindset, Medical Technical background is an advantage.,
- At least 3 years of experience in Quality Assurance and Regulatory affairs in a MedTech environment.
- Analytical individual with a hands-on mentality and strong communication skills.
- High standards for quality, even under time constraints.
- Strong report writing and effective communication skills in Dutch and English (knowledge of other languages is also welcome).
- Proven track record of maintaining certification to ISO13485:2016.
- Knowledge of the MDR (EU) 2017/745). Other Medical device related international standards and regulations IEC 60601, IEC 62304 and IEC62366 are an advantage.
- Basic knowledge of MDSAP and relevant country requirements.

**What do we offer you?**

If you work for us, we will offer you a job with a lot of freedom and independence. You will receive a good, market conform salary, depending on your work experience and knowledge. We also have a number of attractive secondary employment conditions (including pension scheme, work-from-home options). Personal development is important for us so we try to facilitate and accommodate for this as much as possible. The QA & RA Officer reports to the Quality Assurance & Regulatory Affairs Manager / PRRC.

Soort dienstverband: Fulltime, Parttime, Uitzicht op vast, Bepaalde tijd
Contractduur 12 maanden

Verwacht aantal uur: 32 per week

Aanvullende vergoedingen:

- Vakantiegeld

Arbeidsvoorwaarden:

- Bedrijfsfeesten
- Kerstpakket
- Pensioen
- Reiskostenvergoeding
- Werk vanuit huis
- Winstdeling

Werkschema:

- ma-vr

Ervaring:

- QA/RA: 3 jaar (Gewenst)

Taal:

- Nederlands (Vereist)

Werklocatie: Hybride werken in 3833 GZ Leusden