Back to searchMedical Device Lead Auditor
Kenton Black - Science & Engineering
Posted 2 days ago, valid for a month
Birmingham, West Midlands B4 6FQ
£30,000 - £36,000 per annum
Full Time
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Sonic Summary
- The position of Medical Device Auditor is available for remote work in the UK and requires travel to client sites.
- Candidates must have proven experience in the healthcare or medical device industry, particularly in quality management, with a minimum of 3 years of relevant experience.
- The role offers a competitive salary ranging from £40,000 to £60,000, depending on experience and qualifications.
- Key responsibilities include conducting audits, managing projects, providing technical support, and ensuring compliance with medical device regulations.
- Applicants should possess a university degree in relevant sciences and a full UK driving license, with additional desirable qualifications such as IRCA lead auditor certification.
Location: Remote , UK Based
Travel: Will be required
Our client is looking for a Medical Device Auditor to plan and conduct professional management system audits in accordance to the companys procedures.
Key Responsibilities:
Conduct audits at client sites or remotely to meet regulatory and stakeholder requirements.
Complete all chargeable work within budget and timelines to ensure customer satisfaction.
Manage specific projects related to medical device procedures, systems, and documentation.
Provide accurate and timely reporting for planning and operational management.
Oversee auditing teams to enhance client satisfaction and ensure compliance.
Manage personal schedule to meet chargeability targets.
Provide technical support and training to staff both in the UK and internationally.
Support business development efforts, including sales visits and event participation.
Conduct internal audits to ensure compliance with standards.
Maintain and update personal training records and certifications.
Qualifications & Experience:
Essential:
Proven experience in the healthcare or medical device industry, with experience in quality management.
Strong knowledge of medical device regulations: EU MDD 93/42/EEC, MDR 2017/745, IVDR 2017/746, UK MDR 2002, ISO 13485, MDSAP.
Experience in regulatory affairs, quality management, or clinical evaluations.
Competent in using MS Office and large databases.
Full UK driving license.
University degree or equivalent in relevant sciences (e.g., Medicine, Pharmacy, Biochemistry, Biomedical Engineering).
Desirable:
Registered IRCA lead auditor or similar certification.
Experience in reviewing technical documentation and audit packs.
