Vacancy Senior QA Specialist – Almere
8 SEP ’22: For a scale-up organisation which is developing a unique innovative class III medical device, we are seeking a Senior 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 Senior Quality Assurance Specialist. You will lead QA improvements and optimise projects within the organisation.
Additional tasks are:
- Releasing/qualifying product, 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;
- Support the QA Manager with the following processes: Management Review, Design and Process changes, Complaint handling/vigilance, Audits by Notified Body or third parties;
- Compiles and maintains all quality assurance, performance proficiency, and training records for new and current employees;
- Perform the QA review and approval of change requests, quality investigations (Deviations, Product Complaints), Validation Plans, and standard operating procedures;
- Ensuring CAPA management;
For the position of Senior Quality Assurance Specialist, we are looking for a professional with at least a Bachelor’s degree in a life sciences-related study. A minimum of three years of experience in QA Engineering or a manufacturing environment would be ideal. Furthermore, an ideal candidate would have:
- Strong experience in quality improvement;
- Experience with lean six sigma is a big plus;
- Fluent in English; Dutch is a plus
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 the highest potential of each of their colleagues. 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.
Senior Associate | Medical Devices
+31 6 12 43 13 59