Medical Device ISO Auditor
Job in
Cape Town, 7100, South Africa
Listing for:
LRQA
Full Time
position
Listed on 2026-02-05
Job specializations:
-
Healthcare
Medical Science
Job Description & How to Apply Below
Position: Medical Device ISO 13485 Auditor
Job :
Location:
Cape Town : K and K Centurion
Position Category:
Assessors
Position Type:
Employee Regular
Medical Device Auditor ISO
Position
- Full time LRQA
Location - to be based in a major city in South Africa
As an established third-party auditing Organization, 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 assessment against the requirements of ISO.
Therefore 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 organization. Responsible, dedicated Assessors like you help our clients to manage their systems and risks so they can improve their 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 viz. biomedical science, microbiology, chemistry, biochemistry or bioengineering, human physiology, medicine, pharmacy, physics or biophysicsIn 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 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 abroadAnalytic insight and proactive attitudeCommunicative and social skillsQualification to other schemes ISO , ISO & ISO will be an added advantage.This is only for permanent resident of South AfricaPre-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.
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