Company Description
We are delighted that you're thinking about a career with SGS!
We currently have an exciting opportunity at SGS for an In-vitro diagnostic Medical Device Auditor to join our highly successful certification division
SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Job Description
The successful candidate will be responsible primarily for planning and conducting audits of in-vitro 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 IVD’s, 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: Field-based (UK)
- Travel: Mainly within the UK, a Company car or car allowance provided
- Bonus scheme
- Salary: From £65,000 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 ‘hands-on’ 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:
- IVD’s and Medical devices (active, non-active 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.