ISO 13485 Medical Auditor

About Uplift

Uplift is a dynamic agency specializing in global talent search covering EMEA LATAM USA and APAC. With successful placements in 60 countries we combine speed and cutting-edge technology to source top executive and mid-senior talent across various functions. Our innovative approach integrates global networks AI and advanced recruitment tools. Beyond recruitment we engage with our audience through our podcast newsletter and webinars ensuring we stay at the forefront of talent acquisition and global HR trends.

About Our Client

Our client is a global assurance partner supporting thousands of clients across 150 countries with auditing certification and advisory services in quality safety and sustainability.

We are looking for Senior Auditor / ISO 13485 for their organization in Johannesburg South Africa.

The main responsibility will be to perform assessment against the requirements of ISO13485.

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.

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.

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.