Job details

IVD Medical Device Lead Auditor

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 in the South Region.

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

Your role will be to assess in-vitro diagnostic medical devices for strict compliance with the relevant European laws (EU IVDR; Regulation 2017/746). You key task will be carrying out reviews of the manufacturers' technical documentation as part of the CE marking process. This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail.

The successful candidate will be responsible for planning and conducting audits of medical devices to EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485 and MDSAP, enabling the delivery of assessment and certification services that meet customer and regulatory requirements by appropriate accreditation requirements.

Key Accountabilities:

Conduct audits at clients’ sites and remotely, by established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
Work alone or lead audit teams as appropriate, enhance client satisfaction and ,ensure compliance with standards and regulatory requirements.
Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
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 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:

Medical devices (active, non-active or software) and Medical device management systems.
EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485.
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.

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.

What You Should Know About IVD Medical Device Lead Auditor, SGS

Join the dynamic team at SGS as an IVD Medical Device Lead Auditor and take your career to new heights! We're looking for a passionate individual to assess in-vitro diagnostic medical devices, ensuring they meet stringent European regulations like the EU IVDR. This role isn't just about compliance; it's an exciting opportunity to delve deep into the heart of medical technologies while being part of a company that values innovation and encourages you to think outside the box. You'll be responsible for reviewing technical documentation, planning and performing audits both on-site and remotely, and enhancing client relationships through exceptional service delivery. With a background in manufacturing, testing, or quality management of medical devices, combined with a degree in a relevant science, you’ll navigate through safety and regulatory requirements with ease. Your keen eye for detail will shine as you help maintain the high standards SGS is known for. If you've got that four years of hands-on experience, complemented by a strong commitment to quality, we want you to apply! This is your chance to thrive in an environment that’s devoted to helping you reach your full potential while making a significant impact in the healthcare sector.

Frequently Asked Questions (FAQs) for IVD Medical Device Lead Auditor Role at SGS

What are the key responsibilities of an IVD Medical Device Lead Auditor at SGS?

As an IVD Medical Device Lead Auditor at SGS, your primary responsibilities include assessing in-vitro diagnostic medical devices for compliance with European regulations, planning and executing audits, both at client sites and remotely, and reviewing manufacturers' technical documentation as part of the CE marking process.