Site Auditor for Active and Non-Active Devices
Location: Remote Role
A leading global Medical Device manufacturer is currently seeking to hire a Site Auditor for Active and Non-Active Devices to join their growing team in Europe. You will play a key role in the company's growth strategy and success of their business.
Additionally, you will be able to make an immediate impact on their European operations with leading MedTech manufactures.
Key responsibilities of the Site Auditor for Active and Non-Active Devices include:
- conducting quality management system reviews by conducting on-site auditing of manufacturers, suppliers or subcontractors to the manufacturer in accordance with MDR for both initial certification, surveillance audits and recertification audits.
- Develop audit program and advise the audit team, and in particular the audit team leader, on aspects of the manufacturer's design or production processes which could be of particular relevance for the on-site audit.
- Coordinate own conformity assessment activities with relevant departments and stakeholders.
- Plan, conduct, report the internal audit
- Conduct verification activities on certified product(s) or device range covered by QMS for changes and/or modifications on manufacturers quality management system and approved products
Key requirements of the Site Auditor for Active and Non-Active Devices include:
- University (B.Sc.) or technical college degree in relevant studies such as medicine, pharmacy, engineering, or other relevant sciences.
- Over six years of work experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research.
- Minimum two of the six years shall be in the design, manufacture, testing or use of the device or technology to be assessed, or gained the experience as an assessor for a medical device notified body.
- Strong knowledge about the medical device standards and EU legislation
- Excellent verbal and written communication skills in English
- Flexible to travel
If you are interested in the role, apply online today, call +44 203 667 8385 or email your updated CV for a confidential chat.