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- Tasks: Conduct audits of medical devices, ensuring compliance with standards and regulations.
- Company: Join SGS, a global leader in inspection and certification services, known for innovation and excellence.
- Benefits: Enjoy competitive salary, private medical cover, generous leave, and discounts on gym memberships.
- Why this job: Be part of a passionate team that values new ideas and personal growth while making a real impact.
- Qualifications: 4 years of experience in medical device design or testing, plus a relevant degree.
- Other info: Field-based role with travel across the UK; company car or allowance provided.
The predicted salary is between 52000 - 78000 £ per year.
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 and welcome people who challenge the way we do things. We are committed to helping you reach your full potential.
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.
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.
Medical Device Lead Auditor employer: SGS
Contact Detail:
SGS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Lead Auditor
✨Tip Number 1
Familiarise yourself with the latest regulations and standards related to medical devices, such as EU MDR and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience as auditors. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge in your application.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to conduct audits and manage compliance. Highlight any challenges you've faced and how you overcame them, as this will illustrate your problem-solving skills.
✨Tip Number 4
Research SGS as a company and understand their values and mission. Tailor your conversation to align with their focus on innovation and customer satisfaction, showing that you're not just looking for a job, but are genuinely interested in contributing to their success.
We think you need these skills to ace Medical Device Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Medical Device Lead Auditor position. Tailor your application to highlight relevant experience in auditing and knowledge of medical device regulations.
Craft a Strong CV: Your CV should clearly outline your professional experience, particularly in designing, manufacturing, or testing medical devices. Emphasise your familiarity with Quality Management Systems and any relevant certifications, such as being a registered IRCA lead auditor.
Write a Compelling Cover Letter: In your cover letter, express your passion for the role and the company. Highlight specific experiences that demonstrate your ability to conduct audits and ensure compliance with medical device standards. Make it personal and show how you align with SGS's values.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role that involves regulatory compliance.
How to prepare for a job interview at SGS
✨Know Your Standards
Familiarise yourself with the relevant medical device regulations such as EU MDD, EU MDR, and ISO 13485. Being able to discuss these standards confidently will demonstrate your expertise and commitment to quality.
✨Showcase Your Experience
Prepare to discuss your hands-on experience in designing, manufacturing, or testing medical devices. Highlight specific projects where you contributed to quality management systems or regulatory affairs.
✨Demonstrate Leadership Skills
As a Lead Auditor, you'll need to lead audit teams effectively. Be ready to share examples of how you've successfully led teams or worked independently to enhance client satisfaction and compliance.
✨Engage with Questions
Prepare thoughtful questions about the company's culture, values, and expectations for the role. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
