Trainee Medical Devise Auditor

Job Description Job Title: Trainee Medical Device Lead Auditor  Job Type:  Permanent Hours:   hours per week Job Location:  Field-based (UK, South Region) Travel:  Within the UK, a Company car or car allowance provided

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

We have an excellent opportunity for a Trainee Medical Device Lead Auditor to join our global organisation. 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 in accordance with appropriate accreditation requirements.

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.

---