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 Operations / QA & RA department is looking for a Supplier Quality Officer to join the team!
Supplier Quality 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 Supplier Quality Assurance 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 Supplier Quality support with several (Supplier) Quality Assurance tasks and processes which are key for the continuous compliance of the Quality Management System (QMS) as well as compliance with all applicable standards and regulations for the medical devices developed and manufactured by Cablon Medical and the products that we distribute (Radiology and Pharma).
Your Key Activities:
- Conduct, document and follow-up on Supplier (desktop) audits.
- Create SOP/Work instructions that help to ensure that the Quality management system is in compliance with ISO 13485:2016 and (EU) 2017/745 MDR requirements.
- Conduct Trend analysis on supplier performance and carry out annual supplier evaluation
- Support improvement projects with regard to supplier quality and work closely with other departments
- Initiate Supplier Quality Agreements and set up KPIs
- Create-, support- and monitor CAPA’s and SCARs ensure due dates are met.
- Assist with the review of Supplier change notifications, pricing and rollout within the QMS and AFAS system
- Implement, monitor and optimize the quality processes and assist the Process owners with measuring and improving their processes.
- Participate and provide support during External Quality audits and perform Internal Audits.
- Maintain and further structure (processes in) the ERP system (AFAS InSite / AFAS Profit)
Desired Skills and Experience(s):
- HBO+, or HBO+ mindset,
- At least 3 years of experience in Supplier Quality Assurance in a MedTech environment.
- Analytical and pragmatic individual with a hands-on mentality and strong communication skills.
- High standards for quality, even under time constraints.
- Strong writing and effective communication skills in Dutch (native) and English
- Proven track record of maintaining certification to ISO13485:2016 and knowledge of (EU) 2017/745.
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 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 Supplier Quality Officer reports to the Quality Assurance & Regulatory Affairs Manager / PRRC.
Apply Now!
Do you see yourself working at Cablon Medical? Apply immediately! Send your motivation letter and CV to Anne Tiggelaven, HR Manager via HRM@cablon.nl. Would you rather know more about the position first? Call Monique Albinus QA & RA Manager at 033-494 3964.