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Medical device lead auditor

Field
Permanent
Lead auditor
Posted: 23 May
Offer description

Job Description Job Title: Medical Device Lead Auditor - Non active, Sterile Job Type: Permanent Hours: 37.5 hours per week Job Location: Field-based (UK - South) 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. The successful candidate will be responsible primarily for planning and conducting audits of sterile medical devices. The role will include auditing to EU and UK Medical Device Regulations and ISO 13485 Quality Management System Standard enabling the delivery of assessment and certification services that meet customer, regulatory and accreditation requirements. We are looking for candidate who are currently approved as a Medical Device Regulatory Lead auditor. We will also provide full training to candidates with suitable knowledge and ‘hands-on’ experience in design and manufacture of medical devices, including different sterilisation techniques e.g. Radiation per ISO 11137, Ethylene Oxide per ISO 11135, Moist Heat per ISO 17665 or Aseptic Processing per ISO 13408. Training to enable qualification under all schemes will be provided. Key Accountabilities: Conduct audits at customers’ sites and remotely, by using established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. Work alone or lead audit teams as appropriate, enhance customer satisfaction and ,ensure compliance with standards and regulatory requirements. Complete all work within the required budget and timeframes Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

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