Vacancy QA Specialist – Utrecht
17 AUG ’22: For a start-up organisation, that is developing a unique innovative class III medical device, we are seeking a Quality Specialist. This Utrecht based start-up is currently working on a highly innovative product with strong quality and safety standards. This company produces its products in cleanroom environments and the production processes are subject to the applicable industry standards and regulations for the medical devices industry.
The Quality Assurance & Regulatory Affairs (QA/RA) officer ensures, under the direction of the Director QA/RA that the Quality Management System (QMS) is described, effectively implemented and maintained throughout the organisation in accordance with the Company Quality Policy and all relevant and applicable legislations and industry standards (e.g. MDR, EN ISO 13485). The QA/RA officer facilitates the promotion and awareness of applicable regulatory requirements and the QMS requirements throughout the organisation and reports to the Director QA/RA on the effectiveness of the QMS and any need for improvement. The QA/RA officer provides support in the implementation of Quality Objectives as agreed in the Management Review Meetings in order to achieve these objectives. The QA/RA Officer is responsible for the Document and record control, the supplier control, the CAPA management and change management.
QA related tasks and responsibilities:
- Planning of (internal) audits, providing support during the audit and follow up of audit findings;
- Review of equipment maintenance and calibration reports;
- Review of batch manufacturing records and QC test results;
- Review and evaluation of production deviations, out of specification reports and nonconforming product reports;
- Data analysis and trend reporting of Key Performance Indicators of QMS processes.
RA related tasks:
- Identification, evaluation and implementation of applicable regulatory requirements into the QMS;
- Maintaining the technical documentation and the EU declaration of conformity;
- Supporting activities related to the approval and registration of Medical Devices in the aimed for markets.
For this position we are looking for a professional who is willing to learn! Someone who can work independently with a proactive mindset, but is also able to work as a teamplayer between the different disciplines.
- BSc or higher in Life Sciences, or relevant other field;
- At least 1 year professional experience in QA and/or with Quality Management Systems relating to (in vitro) medical devices, OR;
- At least 3 years in a QC/Production function within a company under ISO13485 or GMP.
In this function, you will work with a highly innovative product. Furthermore, this organisation can offer you the following in return:
- Competitive salary;
- A dynamic working atmosphere and an informal culture with after work drinks and fun activities;
- Ability to grow your skills in a rapidly growing company.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Senior Associate | Medical Devices
+31 6 12 43 13 59