Thirona’s most recent achievements driven by the QA/RA department are a successful MDR renewal audit, achieving MDR compliance of the technical files of our three products and taking part in the initial ISO 27001 and NEN 7510 certification. Some big challenges for the coming period include the transition to a more suitable eQMS, the implementation of MDSAP and boosting GDPR. Therefore, we are searching for an enthusiastic, motivated and hands-on QA professional to complement the current team in the maintenance and improvement of the Quality Management System.
In this role you will focus on:
- Driving continuous improvement through CAPA management, Complaint Management, Internal auditing, Supplier/Distributor Management and Risk management activities
- Promoting quality assurance within the company and provide training for colleagues to extend their knowledge on QA matters
- Identifying, initiate and follow up on changes in the QMS
- Supporting the software development team throughout the software development process
- Supporting in (implementation) projects to manage necessary changes in the QMS
- Providing management with input (reports) for Management Review
Profile & Competences:
- Higher professional education and at least 4 years of relevant work experience
- Good understanding of the following standards:
- ISO 13485 quality management systems
- ISO 14791 risk management
- IEC 62304 medical device software – software life cycle processes
- Knowledge of the (EU) 2017/745 Medical Device Regulations
- Excellent verbal and written English communication skills (level C1)
- Customer and service minded, practical, proactive.
- Excellent communication and interpersonal skills.
- Team player and able to positively influence others
- The current QA/RA team consists of two persons, in total Thirona has +/- 40 employees
- The candidate must be either living in the Netherlands or willing to move to the Netherlands
- 32-40 hours (1 day working from home is allowed in case of 40 hours employment)
- 25 vacation days, and 8% holiday allowance
- Flexible pension plan is offered by Thirona, and 8% pension allowance
Nijmegen, the Netherlands
- Be part of an international, multicultural environment (+/- 12 nationalities) with young and motivated colleagues
- Join a fast-growing company that enables you to grow both professionally and personally
- Increase your level of knowledge by working with high educated and skilled colleagues and exploring training opportunities
- Thirona offers a competitive salary, depending on your education, knowledge, and experience
Please send your motivation letter together with your CV to firstname.lastname@example.org or apply with your LinkedIn profile and send along your resume and a motivation letter.
The first employment contract will be for the duration of one year. After this period, in case of proven suitability, an employment contract with indefinite duration is offered.
* Applying for and submitting a certificate of conduct is part of the hiring process.