Medical Device Lead Auditor

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**:

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Job Title: Medical Device Lead Auditor**:

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Job Type**:Permanent
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Hours**: 37.5 hours per week
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Job Location**:Multiple Location, including London, Birmingham, Manchester, Bristol, Southampton UK, Field based
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Travel**:Within UK. Company car or car allowance provided
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Salary**: Competitive salary
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Benefits / perks**:Generous** **annual bonus, Private Medical Cover, 4-8% matching company pension contributions, 4x Life Assurance, 25 days Annual Leave (increasing with service) plus bank holidays, Birthday Leave Scheme, Enhanced maternity/paternity and adoption pay, Length of Service Awards, Health & Wellbeing initiatives, Christmas Vouchers.

**Key Accountabilities**:
In the first four to six months you will be trained to be a Medical Device Auditor and subsequently a Lead Auditor with the following accountabilities:

- Conduct audits at clients’ sites and remotely, in accordance with 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 in relation to 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