Medical Device Auditor for South Africa

Lrqa; Johannesburg; On-site; ZAR 30 000 - 60 000; Full time

Job summary

An established industry player is seeking a skilled professional to lead business assurance assessments within the medical device sector. This role involves conducting thorough evaluations, producing detailed reports, and ensuring compliance with accreditation standards. The ideal candidate will possess a strong educational background in biomedical sciences or related fields, along with significant experience in the medical device industry. You'll have the opportunity to build strong client relationships and contribute to innovative projects, all while maintaining your professional development in a dynamic environment. If you're ready to make a meaningful impact, this position is perfect for you.

Qualifications

• Minimum four years in medical device industry, including R&D and compliance testing.
• ISO 13485 knowledge and IRCA Lead auditor training required.

Responsibilities

• Conduct business assurance assessments and lead assessment teams.
• Produce high-quality reports and maintain client relationships.

Skills

Analytic insight

Communicative skills

Social skills

Technical writing

Education

BSc degree in biomedical science

Higher diploma in microbiology

Job description

Key Responsibilities

Within authorised area of specialism, undertake business assurance assessments in accordance with current procedures and agreed timescales.

Lead assessment teams effectively, ensuring that the visit is completed within the agreed timescales, and co-ordinating team findings to reach conclusions.

Produce high quality assessment reports reflecting business assurance principles in compliance with accreditation requirements and internal procedures.

Ensure that all internal client stakeholders are kept informed of changes and issues, escalating as appropriate.

Pass opportunities and sales leads to appropriate colleagues to progress.

Pass client feedback and insights to appropriate internal recipients.

Maintain professional competence by keepingabreast of technical and other developments in own area of expertise, maintaining CPD records, updating CV, maintaining professional registrations and producing records of competence as required.

Actively build strong client and internal relationships.

Participate fully in Assessor meetings.

Perform additional and ad hoc tasks promptly as required such as assessor development, product development or projects.

Technical/Professional qualifications/Requirements

BSc degree, higher diploma or equivalent in one or more professional areas viz. biomedical science, microbiology, chemistry, biochemistry or bioengineering, human physiology, medicine, pharmacy, physics or biophysics

In general, a minimum of four years full-time work experience in a medical device related industry, including two years in one or more of the following: research & development, manufacturing, application of the device in a clinical setting, testing of devices for compliance with standards, conducting performance testing, evaluation studies, clinical trials.

Wider knowledge of ISO 13485 Standard; must have successfully completed IRCA regd. Lead auditor training courses.

Third-party auditing experience in the relevant sector with an IAF recognized certification Body.

Being familiar with relevant International/local laws and industry regulations.

A good verbal and written knowledge of the local and English language.

Preparedness to travel when necessary to visit locations abroad

Analytic insight and proactive attitude

Communicative and social skills

Qualification to other schemes e.g. ISO 9001, ISO 14001 & ISO 45001 will be an added advantage.