Lead Auditor Medical Devices Regulations

Responsibilities

• Perform independent audits against Medical Devices Regulation (MDR), ISO 13485, MDSAP, and UK Medical Devices Regulation
• Conduct physical on-site inspections and desk research/document studies
• Develop action plans for improvement when non-conformities are found
• Write detailed reports based on audit findings
• Report directly to the Field Manager

Requirements

• University or technical university degree in medicine, pharmacology, biomedical/bio-engineering, microbiology, biotechnology, biochemistry, health technology, mechanical engineering, or electronic engineering
• At least four years of professional experience in the medical device industry
• At least two years of experience in quality management
• Significant experience in the manufacturing of active medical devices
• Valid driver's license

Preferred Qualifications

• Experience in quality management/engineering within active medical device manufacturing
• Production roles such as production manager, QC manager, or R&D roles
• Experience with sterilization processes, techniques, or software
• Demonstrable experience with ISO 13485, MDSAP, or UKCA Mark
• Knowledge of MDCG endorsed and guidance documents
• Experience with manufacturing processes like metal/plastic processing, cleanroom production, or electronic component assembly

About the Company

SGS is the world's leading inspection, verification, testing, and certification company.