Medical Devices Quality Assurance Lead
2 maanden geleden
About LRQA
LRQA is a leading global assurance provider dedicated to delivering exceptional services to our clients. With a strong commitment to risk management, we have grown to become a trusted partner in certification, customized assurance, cybersecurity, inspection, and training.
Our Mission
We strive to support our clients in building a safer and more sustainable future by staying true to our shared values and combining decades of collective experience. Our team of experts works tirelessly to deliver high-quality services that meet the evolving needs of our clients.
Key Responsibilities
- As a lead auditor and specialist in your field, you will independently or in a team verify management systems in the area of quality management mainly within the medical devices industry (ISO 13485 and ISO 9001).
- You will act as an expert and examine and assess the implementation of management systems at our clients across various sectors. Your goal is to contribute to the improvement of the overall systems.
- The broadening and deepening of the collaboration with our relations is also a great aspect of your job.
- You will be the point of contact for your customers, maintaining contact with them and ensuring that their questions are directed to the right internal teams for resolution.
Requirements
- A minimum of a BSc degree, higher diploma, or equivalent in a relevant science subject (Mechanical Engineering or Electronics), as well as relevant postgraduate experience gained within the IVD industry, a clinical laboratory, or medical research institution.
- At least 5 years of working experience in the field of medical devices or relevant sectors, preferably in various sectors.
- Wide knowledge of ISO 13485 and ISO 9001 Standards; Preferably successfully completed IRCA registered Lead Auditor training courses.
- Third-party auditing experience in the relevant sector.
- A good verbal and written knowledge of both Dutch and English language.
- Preparedness to travel when necessary to visit locations abroad.
- Analytic insight and proactive attitude.
- Qualification to other schemes ISO 14001 and ISO 45001 will be an added advantage.
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