IVD Medical Device Lead Auditor
IVD Medical Device Lead Auditor
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Job Description
The successful candidate will be responsible primarily for planning and conducting audits of invitro diagnostic medical devices to EU IVDR (EU Regulation 2017/746). The role will also include auditing to EU MDR (EU medical device regulation 2017/745) UK MDR 2002 for medical devices and IVDs ISO 13485 and MDSAP enabling the delivery of assessment and certification services that meet customer regulatory and accreditation requirements. Training to enable qualification under all schemes will be provided.
Summary of role:
- Job Title: IVD / Medical Device Lead Auditor
- Hours: 37.5 hours per week
- Job Location: Fieldbased (UK)
- Travel: Mainly within the UK a Company car or car allowance provided
- Bonus scheme
- Salary: From 65000 Depending on Experience
Key Accountabilities:
- Conduct audits at customers sites using established procedures maintaining a high standard of service delivery that ensures effective customer relationships.
- Work alone or lead audit teams as appropriate enhance customer satisfaction and ensure compliance with standards and regulatory requirements.
- Complete all work within the required budget and timeframes
- Complete specific projects about medical device procedures processes systems and documentation as requested by the Medical Devices Manager
Qualifications :
- A minimum of 4 years handson professional experience of designing manufacturing or testing IVD medical devices:
- 2 years of the 4 years from working within a formal Quality Management System or working in Quality Management /Regulatory Affairs.
- A university degree or equivalent qualification in relevant sciences such as: Chemistry Biochemistry Biology Microbiology Biotechnology Physics Biophysics Material Science Biomedical Engineering Mechanical Electrical or Electronic Engineering Computer & Software Technology.
Knowledge of:
- IVDs and Medical devices (active nonactive or software) and Medical device quality management systems.
- EU IVD Directive 98/79/EC EU IVD Regulation 2017/746 EU Medical Device Directive 93/42/EEC EU Medical Device Regulation 2017/745 UK Medical Device Regulation ISO 13485.
- IVD and Medical Device Standards.
In addition:
- Experience of working under own initiative and in planning and prioritising workloads.
- Full driving licence for use in the UK.
- Good English written and verbal skills.
- Willingness to travel Internationally if required.
The following attributes would be desirable but not essential:
- Knowledge of MDSAP.
- Registered IRCA lead auditor or equivalent registration under other recognised body.
- Experience in delivering training and in engaging and working with people in all levels of an organisation.
Additional Information :
APPLY NOW for full consideration you can be sure that your application will be treated confidentially and impartially and you will always receive an update within 10 business days.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
