Medical Device Lead Auditor

SGS; United Kingdom; Remote; GBP 65,000 - 80,000

Job description

Company Description

We are delighted that you're thinking about a career with SGS!

We currently have an exciting opportunity at SGS for a Medical Device Auditor to join our highly successful certification division in the South Region.

SGS is 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

• Job Title: Medical Device Lead Auditor - Non active
• Job Type: Permanent
• Hours: 37.5 hours per week
• Job Location: Field-based (UK, ideally Midlands based)
• Travel: Within the UK, a Company car or car allowance provided
• Salary: From £65,000

At SGS, we believe in rewarding our employees for their hard work and commitment. As part of our team, you would be eligible for:

• Retention bonus scheme (Bonus rises each year of employment)
• Private medical cover (subject to eligibility criteria)
• Competitive pension scheme + Life Assurance
• Generous Annual Leave allowance (increasing with service) plus bank holidays.
• An additional day off for your birthday
• Discounted Gym Membership
• Retailer Discounts
• Access to electric vehicle leasing scheme (subject to eligibility criteria)
• Enhanced maternity/paternity and adoption pay.
• Length of Service Awards
• Christmas Vouchers
• Health & Wellbeing initiatives

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 at 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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