Trainer & Auditor (Medical Devices - IVD)

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. 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.

At SGS, we have an open corporate and international culture, we offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company.

Job Description

• Job Title: Trainer & Auditor (Medical Devices - IVD)
• Job Type: Permanent
• Hours: 37.5 hours per week
• Job Location: Camberley
• Company car provided
• Travel: Yes
• Remuneration: As Trainer and Auditor for Medical Devices, you'll receive a salary of between £50,000 - £60,000 per annum, depending on experience level, plus you'll benefit from a 10% performance bonus private health cover, a contributory pension scheme and life cover

You'll be responsible for acting as the main contact point for all IVD auditors, ensuring appropriate training is provided and resources are available to deliver on the scheme requirements. You'll plan and conduct audits/reviews and deliver training courses for clients. You'll also liaise with the UKCA medical devices Certification Manager, and provide input into the technical and procedural requirements for IVD UKCA certification and assessment and to ensure SGS comply with these requirements.

Key Accountabilities;

• Support the UKCA Medical devices Certification Manager with regulatory body audits in relation to IVD to ensure we maintain our Approved Body Status.
• Develop and maintain strategic growth plans for IVD services, working with the Head of Sales and Marketing, operations managers and Academy Manager to ensure all aspects of the customer journey are covered.
• Conduct audits at client's sites or remotely, in accordance with established procedures, to meet applicable regulatory requirements & those of other applicable stake-holders, in order to maintain a high standard of service delivery that ensures effective customer relationships
• To provide technical support and staff training to all parts of the business to enhance the service capability of the business, and knowledge within the teams.
• To plan and conduct QMS and Regulatory audits
• To develop and deliver training courses in QMS and Regulatory Requirements as requested.
• Assist with the recruitment of employees and contracted auditors to ensure competence requirements are met.

Qualifications

To be successful in this role, you'll be able to demonstrate working knowledge of IVD medical device management and regulatory systems, standards and compliance/auditing techniques and hold a University degree (or equivalent higher educational qualification) in a directly relevant technical subject (biochemistry, microbiology, chemistry etc)

• Have an understanding of ISO 13485, Directive 98/79/EC (as equivalent to UKCA SI 618 2002 amended 2021), recognised device standards, European Union devices legislation including guidance
• A broad base of knowledge of different manufacturing processes, technologies and performance evaluation of a range of IVD devices across different risk classifications for IVD devices

In addition to the above you'll also need to demonstrate the following;

• A solid background in a relevant field of IVD medical devices or related activities e.g. work in IVD industry such as research and development, manufacturing, testing.
• Knowledge of technologies, design and manufacturing of IVD medical devices, experience of different manufacturing processes and performance evaluation of a range of IVD devices across different risk classifications for IVD devices
• Relevant professional experience to include quality management
• 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

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