16 Medical Device jobs in South Africa

Job ID :

Location : ((location_obj))

Position Category : Assessors

Position Type : Contractor On Demand

ISO Medical Device Auditor, South Africa

Location to be based in a major city in South Africa

As an established third-party auditing organization, we are looking for an Auditor to support our activities in the medical devices field. The main responsibilities include performing assessments against ISO requirements.

Bring your management systems audit skills and medical device industry experience to our Management Systems Lead Assessor role and utilize your professional skills in meaningful work.

Our organization sets international standards of excellence in safety. Responsible Assessors like you help our clients manage their systems and risks, improving their current and future performance. Join our global assessment team and be inspired by your work.

Key Responsibilities

• Conduct business assurance assessments within your area of expertise, following current procedures and timelines.
• Lead assessment teams effectively, ensuring completion within scheduled times and coordinating team findings.
• Produce high-quality assessment reports in line with business assurance principles, accreditation requirements, and internal procedures.
• Keep internal stakeholders informed of changes and issues, escalating as necessary.
• Pass opportunities and leads to colleagues for further action.
• Share client feedback and insights with relevant internal teams.
• Maintain professional competence by staying updated on technical developments, maintaining CPD records, updating your CV, and professional registrations.
• Build and maintain strong client and internal relationships.
• Participate actively in assessor meetings.
• Perform additional tasks as required, such as assessor development, product development, or projects.

Technical / Professional Qualifications / Requirements

• BSc degree, higher diploma, or equivalent in biomedical science, microbiology, chemistry, biochemistry, bioengineering, human physiology, medicine, pharmacy, physics, or biophysics.
• Minimum of four years full-time experience in a medical device-related industry, including at least two years in research & development, manufacturing, clinical application, testing for standards compliance, performance testing, evaluation studies, or clinical trials.
• Knowledge of ISO standards; successful completion of IRCA-registered Lead Auditor training courses.
• Experience in third-party auditing in the relevant sector with an IAF-recognized certification body.
• Familiarity with relevant international and local laws and regulations.
• Proficiency in English and local language, both verbal and written.
• Willingness to travel as needed for site visits abroad.
• Analytical insight and proactive attitude.
• Strong communication and social skills.
• Qualifications in other schemes (ISO, ISO, ISO) are advantageous.

This opportunity is only available for permanent residents of South Africa.

• iso 134852016 medical device lead assessor

Are you an experienced auditor with a passion for quality in the medical device industry? Join our team as an ISO 13485:2016 Lead Assessor at JC Auditors, a leading conformity assessment body with a client-focused approach to promoting medical device performance and efficacy.

• Employment Type: Freelance Contract
• Industry: Medical Devices | Quality Assurance | Regulatory Compliance
• Experience: Minimum 5 years
• Travel: Extensive

What You'll Do:

• Conduct ISO 13485:2016 audits for medical device manufacturers and suppliers
• Assess compliance with regulatory and quality requirements (SAHPRA)
• Provide expert guidance on risk management, QMS implementation, and continual improvement
• Work with a dynamic team committed to upholding the highest industry standards

What We’re Looking For :

• BSc Degree in one or more health science professional areas (biomedical science, medical science, microbiology, chemistry, biochemistry, bioengineering, human physiology, pharmacy, physics)
• Certified Lead Auditor for ISO 13485:2016 (IRCA registered course preferred)
• Minimum of 5 years work experience in the medical device industry
• Proven experience in auditing medical device organizations and conducting 3 rd party- audits
• Current Audit Log reflecting all completed audits and technical areas
• Strong experience in medical devices, SAHPRA regulatory compliance and quality assurance
• Knowledge of related standards (ISO 14971, ISO 9001) and global regulatory frameworks
• Knowledge of MD5, MD9 and ISO 17021
• Ability to travel
• Excellent communication and stakeholder engagement skills
• Excellent analytical, writing and reporting skills

Why Join Us?

• Work with a globally recognized conformity assessment body
• Opportunity to make an impact in the medical device industry
• Professional growth and continuous learning

• Requirements of the MCC are met before importing medical devices procedure and SOP are clearly adopted
• Managerial responsibilities are defined hereunder
• All necessary controls and validations are carried out on receipt of all goods
• Reporting and recording all non-compliant items as per defined procedures
• Reporting and recording all product returns and warranty issues
• Repair of all warranty good in accordance with the manufacturers agreement

• To approve or reject, as he sees fit any products
• To evaluate batch records
• To ensure that all necessary testing is carried out
• To approve specifications, sampling instructions, test methods and other Quality Control Procedures
• To check the maintenance of his department, premises and equipment
• To ensure that the appropriate validations are done
• To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need

Job Description:

To assist the Technical manager with the implement the Quality Assurance and Quality Control system of all products. Must have experience in electronic repairs.

Location: Milnerton, Cape Town

Responsibilities:

Quality Assurance:

• Requirements of the MCC are met before importing medical devices procedure and SOP are clearly adopted
• Managerial responsibilities are defined hereunder
• All necessary controls and validations are carried out on receipt of all goods
• Reporting and recording all non-compliant items as per defined procedures
• Reporting and recording all product returns and warranty issues
• Repair of all warranty good in accordance with the manufacturers agreement

Quality Control:

• To approve or reject, as he sees fit any products
• To evaluate batch records
• To ensure that all necessary testing is carried out
• To approve specifications, sampling instructions, test methods and other Quality Control Procedures
• To check the maintenance of his department, premises and equipment
• To ensure that the appropriate validations are done
• To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need

Application Process: