Medical Devices Quality Assurance Specialist
2 months ago
BSI is seeking a highly motivated and experienced Medical Devices Auditor to join our EIMEA team.
In this role, you will play a crucial part in ensuring patient safety and facilitating global market access for medical device products. As a renowned Notified Body with over a century of experience, BSI upholds values of integrity, respect, and expertise.
Your Responsibilities- Conduct comprehensive audits of medical device manufacturers to ensure compliance with ISO 13485 standards and other relevant regulations.
- Evaluate the effectiveness of Quality Management Systems (QMS) within the medical device industry, focusing on areas such as Research & Design, Validation, Testing, and Servicing.
- Provide expert guidance and recommendations to manufacturers on improving their QMS processes and addressing identified non-conformities.
- Contribute to the development and implementation of audit methodologies and best practices within the EIMEA region.
We are particularly interested in candidates with a strong technical background in various medical devices, including:
- Ceramics, such as orthopaedic implants (hips, knees, bone plates)
- Bone filler
- Dental composites
- Cements
At BSI, we are committed to fostering a diverse and inclusive workplace where everyone can thrive. We offer a competitive benefits package that includes:
- 27 days of annual leave
- Paid sick leave
- Health insurance
- Life insurance
- Pension plan with company contribution
- Car allowance (dependent on role)
- Income protection
- Various types of paid leaves such as maternity, paternity, parental, adoption, compassionate, and bereavement
- Learning and development opportunities
- Flexible benefits tailored to your lifestyle
If you are passionate about making a difference in the medical device industry and contributing to patient safety, we encourage you to apply.
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