Regulatory Lead Auditor
4 weeks ago
We are looking for a Medical Lead Auditor who will be responsible for the conduct of management system auditing (both scheduled and unannounced) of Medical Device Manufacturers and for conducting audits in accordance with Intertek’s established procedures whilst maintaining a high standard of service delivery.
As the Medical Lead Auditor, you will have accountability to support the operation by providing regular and unannounced auditing activity in regard of the client’s compliance to the appropriate quality system and regulatory requirements, in accordance with:
~ Medical Device Regulations EU 2017/745, EU 93/42/EEC, UK MDR 2002
~ Notified Body quality management systems
~ 4+ years previous professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research of which 2 years will be in the area of quality systems.
~ Appropriate knowledge of quality management systems and related standards and guidance documents
~ Performing audits (scheduled and unannounced) of Medical Device manufacturers against the appropriate quality system and regulatory requirements in a timely and accurate manner, in accordance with documented procedures, tools and forms
Timely management and accuracy of audit documentation in accordance with Intertek’s procedures, including supplying accurate billing information
Planning and performing audits, providing adequate and timely follow up and documentation on issued non-conformities directly with the client
Performing allocated audits in accordance with the technical codes allocated to you
Supplying data to audit coordinators to maintain accurate records
Achieving KPIs for the audit process es including utilisation, turnaround times and customer satisfaction
Compliance with Intertek’s quality management system
The role is full time with extensive and intensive travel (domestic and international)
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace, and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
Competitive salary/benefits
Development and career opportunities around the Globe
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