Medical Device ISO 13485 Auditor

LRQA; South Africa; On-site; ZAR 300 000 - 400 000; Full time

Job summary

A global assurance provider is seeking a full-time Medical Device Auditor based in South Africa. You will conduct assessments against ISO 13485 and lead assessment teams to ensure compliance. The ideal candidate will have a BSc or equivalent in a relevant field and at least four years of experience in the medical device industry. Strong analytical and communicative skills are essential, along with readiness to travel as required.

Qualifications

• Minimum of four years work experience in the medical device sector.
• Two years in related fields like research and development or compliance testing.
• Good verbal and written English and local language skills.

Responsibilities

• Conduct assessments in accordance with current procedures.
• Lead assessment teams and ensure compliance with timescales.
• Produce high-quality reports for business assurance.

Skills

Management systems audit skills

Analytical insight

Communicative and social skills

Education

BSc degree or equivalent in biomedical science, microbiology, or related fields

Job description

Job ID: 42399

Location: Cape Town : K5 and K6 Centurion

Position Category: Assessors

Position Type: Employee Regular

Medical Device Auditor ISO 13485

Position – Full time LRQA

Location – to be based in a major city in South Africa

As an established third‑party auditing organisation, we are looking for a full‑time Auditor to support our existing activities in the medical devices field. The main responsibility will be to perform assessments against the requirements of ISO13485.

Bring your management systems audit skills and medical device industry experience to our Management Systems Lead Assessor role and make the most of your professional skills doing more of the work you enjoy.

Setting international standards of excellence in safety is our purpose as an organisation. Responsible, dedicated Assessors help our clients manage their systems and risks so they can improve current and future performance. Join our global assessment team and be inspired by your work.

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 keeping abreast 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: biomedical science, microbiology, chemistry, biochemistry or bioengineering, human physiology, medicine, pharmacy, physics or biophysics.
• Minimum of four years full‑time work experience in a medical device related industry, including two years in research & development, manufacturing, clinical application, device testing for compliance, performance testing, evaluation studies or clinical trials.
• Wider knowledge of ISO 13485 Standard; must have successfully completed IRCA‑registered Lead Auditor training courses.
• Third‑party auditing experience in the relevant sector with an IAF‑recognised certification body.
• Familiarity with relevant international/local laws and industry regulations.
• Good verbal and written knowledge of the local language and English.
• Preparedness to travel when necessary to visit locations abroad.
• Analytical 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.
• Position is only for permanent residents of South Africa.

Pre‑Employment Checks

If you are successful in securing a role with us, we will carry out pre‑employment checks in accordance with what is allowed under local law.

These checks will include, as permitted: right to work, identification, verification of employment history, education, and criminal records.

We may involve the third‑party supplier to run the background checks as needed and your data will be retained for a period as needed for the purpose of employing you.

Your data will be stored in accordance with all relevant privacy legislation.

Please contact us if you have any questions or concerns.

Diversity and Inclusion at LRQA

We are on a mission to be the place where we all want to work and we are passionate about embracing different perspectives because we understand the value this brings to our business, our clients and each other. We are all about creating a safer and more sustainable future and our inclusive culture is right at the heart of our business.

Together our employees make our communities better and we want you to be part of our diverse team!

LRQA is a leading global assurance provider. The integrity and expertise we bring to our partnership with clients support their journey to a safer, more secure and more sustainable future. (Group entities).