Vacancy Quality Assurance Specialist – Almere
11 NOV ’22: For a scale-up organisation that is developing a unique innovative class III medical device, we are seeking a Quality Assurance Specialist. This organisation produces its products in cleanroom environments and the production processes are subject to the applicable industry standards and regulations for the medical devices industry.
Due to the current growth of the organisation, they are looking to strengthen the team with a Quality Assurance Specialist who will be supporting the QA Manager with the following processes: Management Review, Design and Process changes, Complaint handling/vigilance, and Audits by Notified Bodies or third parties. Furthermore, the Quality Assurance Specialist’s main responsibility will be monitoring, securing, and evaluating the QMS, the ISO 13485, MDSAP, and MDR, to ensure agreed standards of quality are achieved and improved upon.Moreover, you will also be responsible for:
- Releasing/qualifying products, intermediates, equipment, processes, and employees for their purpose;
- Supplier Management including but not limited to Annual Assessments and Quality Assurance Agreements;
- QMS development and maintenance to selected standards/regulations;
- Trend data resulting from processes owned by the QA department and report the outcome. Review trend data from the Operations department;
- Compiling and maintaining all quality assurance, performance proficiency, and training records for new and current employees;
- Performing the QA review and approval of Change Requests, Quality Investigations (Deviations, Product Complaints), Validation Plans, Protocols and Reports, and Standard Operating Procedures.
The organisation is looking for someone who is detail-oriented with the ability to check documents for accuracy and inconsistencies and with the ability to establish genuine, empathetic connections with colleagues and with a passion and alignment with the organisation’s mission, vision, values & operating principles. Furthermore, they are looking for someone with:
- Bachelors’ or master’s degree, technical degree desired (i.e., Engineering, Chemistry, Biology, etc.);
- At least 3 years experience in a QA department within the Medical Device or comparable organisation;
- Extensive knowledge of ISO 13485 standards and practices, MDR or equivalent, MDSAP;
- Well-developed computer skills and fluent with Microsoft office applications;
- Strong verbal and written communication skills in Dutch and English.
Empowered to apply their talents and diverse perspectives in an inclusive culture, their shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out their colleagues’ highest potential. Besides working in a fast-growing organisation with a lot of room for your own input and ideas, the organisation offers the following conditions:
- Competitive salary in line with the market;
- Bonus arrangement;
- Pension plan;
- Growth opportunities.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Associate | Biotechnology & Pharmaceuticals
+31 6 10 46 76 39
+31 23 754 86 60