What You'll Do
Plan and conduct remote and on-site audits of external suppliers to verify adherence to quality standards including ISO 13485 and ISO 9001. Develop audit strategies based on supplier classification, risk profile, and regulatory context. Review historical performance data and prior findings to define audit scope and focus areas.
Evaluate supplier quality management systems, with attention to manufacturing controls, process validation, risk management, documentation integrity, CAPA effectiveness, and design transfer processes. Apply risk-based audit principles to assess how quality processes interact across the organization. Document findings thoroughly and produce clear, actionable audit reports supported by evidence.
Communicate results to internal teams and supplier representatives, ensuring transparency and alignment. Manage follow-up activities including corrective action requests, tracking resolution timelines, and verifying effectiveness of implemented changes. Maintain current knowledge of regulatory updates and revisions to quality standards to ensure audit practices remain current.
Requirements
- Valid certification as a Lead Auditor from a recognized body (e.g., IRCA, RAB-QSA, ASQ, BSI, TÜV) or completion of an approved internal program
- Formal training in ISO 13485 and ISO 9001 standards
- Proven experience auditing external suppliers in medical devices, pharmaceuticals, or regulated manufacturing environments
- Bachelor’s or Master’s degree in Engineering Science, Supply Chain Management, Electrical or Electronic Engineering, or a related field
- Minimum of 7 years in roles such as Quality Engineering, Process Engineering, Safety Engineering, or continuous improvement within regulated industries
- Proficiency with audit management systems and digital documentation tools
Preferred Qualifications
- Knowledge of additional standards such as ISO 17025
- Master’s degree in an engineering discipline
Work Mode
This is a hybrid role with significant travel requirements. You will be expected to travel 30–50% of the time, both domestically and internationally, to visit supplier sites. Flexibility to engage across multiple time zones is essential for coordinating audits and follow-up activities.
