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.
ABOUT YOU
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
- ISO 13485 and MDSAP programmes
- Notified Body quality management systems
- Regulator/Certification Body designation and accreditation requirements including 17021-1
- 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
- Strong communication skill and can build good rapport at all levels
ABOUT THE OPPORTUNITY
- 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)
WHAT WE OFFER
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
- Working in a highly motivated team and dynamic working environment
We are an Equal Opportunity Employer who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.
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