Lead Auditor, ISO 13485 / ISO Consultant

Posted Oct 9

This is a fully remote position, open to applicants in Germany.

📋 Description

• Execute ISO consulting and/or audit projects in line with agreed project and contractual stipulations.

• Develop and deliver assessment reports, audit reports, and presentations.

• Clearly articulate results, findings, and recommendations.

• Create specific, actionable suggestions to rectify nonconformities and enhance management systems.

• Ensure completion of all project-specific documentation and reporting as agreed.

• Continuously update and enhance professional knowledge of management systems, standards, and regulatory requirements.

• Collaborate with clients from diverse industries and across various ISO standards.


⛳️ Requirements

• IRCA certification as an ISO 13485 Lead Auditor or an equivalent qualification (mandatory).

• Proven experience in implementing and/or auditing management systems.

• Exceptional communication skills with the ability to confidently engage a variety of stakeholders.

• Strong self-organization and dependability.

• Capability to handle multiple projects simultaneously.

• Flexibility and adaptability in addressing diverse client needs.

• Operate solely on a self-employed, freelance basis.

• No professional, temporary, or organizational subordination to directives.

• Independent, project-oriented, and results-focused service delivery.


🏝️ Benefits

• Flexible, project-based work without a guarantee of a continuous stream of client assignments.

• Remote work with occasional on-site client interactions.

• Access to a global client portfolio and a well-established ISO consulting network.

• Support from a prestigious international ISO consulting organization.

• Opportunity for project engagement within an international client portfolio, dependent on demand and availability.

• Chance to work across various industries and with different ISO standards.

• Structured support through tools, resources, and established methodologies.

• Collaborative, professional, and inclusive company culture.

• No exclusivity; working with other clients is allowed.

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