Lead Auditor - ISO 13485

IMSM; South Africa; Hybrid; ZAR 500 000 - 700 000; Part time

Job summary

A consultancy firm specializing in ISO standards is seeking a Lead Auditor for ISO 13485. This role involves conducting audits, delivering consultancy, and providing actionable recommendations while engaging with clients in a flexible, hybrid environment across South Africa. The ideal candidate must possess an IRCA certification and have significant experience in ISO auditing and management systems.

Benefits

Professional development opportunities

Inclusive and collaborative workplace culture

Hybrid work environment

Qualifications

• Experience conducting ISO 13485 audits (internal or external) is essential.
• Proven experience in implementing management systems aligned with these standards.

Responsibilities

• Conduct consultancy assignments in accordance with agreed contractual terms.
• Prepare and deliver presentations and assessment reports.
• Provide clear actionable recommendations for improvements.

Skills

Excellent written and verbal communication skills

Strong organisational skills

Ability to multitask

Adaptability and flexibility

Education

IRCA certification (or equivalent)

Job description

This position is offered on a freelance / contractor basis and will be governed by Terms of Engagement or Statement of Work.

About Us

IMSM (International Management Systems Marketing) is a global leader in ISO consultancy, offering high-quality ISO standards and services to organisations of all sizes, across all sectors. Whether large or small, we empower businesses worldwide to unlock their potential through tailored, effective ISO certification services. Our mission is to help companies achieve internationally recognised standards, enhancing their operational efficiency and market competitiveness.

In 2024, IMSM was acquired by Inflexion, becoming part of the Axiom GRC division, which expands our capabilities in the areas of Governance, Risk and Compliance (GRC). With a presence in North America, Canada, APAC, Europe and Africa, IMSM operates on a global scale, bringing expertise and innovation to businesses everywhere.

Join Our Team as a Lead Auditor – ISO 13485

We are looking for a highly qualified and competent ISO 13485 Auditor / Consultant with a strong background in quality management. Our work spans a wide range of industries and business sizes, so your own commercial or industrial experience will be essential in effectively engaging with clients. You will be responsible for delivering consultancy services in line with the contractual arrangements outlined in the current Consultant Handbook.

Role and Responsibilities

• Conduct consultancy assignments in accordance with agreed contractual terms
• Prepare and deliver presentations and assessment reports that clearly communicate findings and decisions to clients
• Provide clear actionable recommendations for addressing any identified non-conformities or areas for improvement
• Ensure accurate and timely updates to client records and internal systems supporting data integrity and compliance
• Maintain and continually develop your technical knowledge and expertise in management systems and relevant standards

Qualifications & Experience

• IRCA certification (or equivalent)
• Experience conducting ISO 13485 audits (internal or external) is essential
• Proven experience in implementing management systems aligned with these standards
• Excellent written and verbal communication skills
• Strong organisational skills with the ability to multitask and prioritise effectively
• Adaptability and flexibility to respond to varying client needs

Part of something greater

IMSM is part of the WorkNest group, bringing together over 800 of the most gifted practitioners and leading software solutions, to offer a broad range of services to help protect and nurture organizations of every size.

From cyber security, and ISO certification to employment law, HR and health and safety, our ambition is clear: to be the most highly valued provider of advice, technology, and services in these fields. With unwavering commitment to excellence, a growing cohort of extremely capable and engaged colleagues, and with the support of Inflexion, we are well on our way to realising this vision and continuing to exceed the expectations of our valued customers across the UK and internationally.

At IMSM, we believe in creating a workplace that is built on collaboration, inclusivity, and continuous growth. We are committed to fostering a culture where Diversity, Equity, and Inclusion (DEI) are fundamental values, and where every team member feels respected, valued and empowered to succeed. We provide opportunities for professional development to help our colleagues' reach their full potential and we strive to create an environment where everyone's voice is heard.

We are proud of our culture, which fosters both innovation and learning, and we are dedicated to building a space where all our team members can thrive and contribute to our collective success. Are you ready to join us?

Department Operations Locations: Cape Town, South Africa; Durban, South Africa; Johannesburg, South Africa. Remote status: Hybrid. Employment type: Contract.