• Support the audit program manager in definition and implementation of comprehensive audit programs and audit methodologies to effectively address identified risks
• Interact with stakeholders at all levels in developing comprehensive audit plan and execution of planned audits
• Perform audits for the various products /suppliers according applicable standard or regulatory requirements (e.g., ISO 13485, MDSAP, EU MDR etc.)
• Formulate complete and accurate reports of the current level of compliance or implementation of the management system
• Ensure that potential issues and areas for improvement are identified, and formulate recommended actions through review of documentation
• Provide timely and accurate reviews of corrections, corrective / preventive actions, and closure
• Provide timely status updates to management by communicating findings, engagement risks, and potential issues
• Actively support the team members on the conduct of assigned audits
• Utilize the potential of digitization to increase the efficiency and productivity of audits.
• Assist in the training of other auditors and lead auditors as necessary
• Maintain the necessary audit qualifications and work to upgrade them as well as any other pertinent certifications as necessary.
• Support in the overall improvement of the Quality management system
Required Knowledge/Skills, Education, and Experience
• 8 to 10+ years of experience in quality management/process engineering/regulatory affairs, R&D, role within the medical device industry (Diagnostic Imaging preferred).
• Certified ISO 13485 auditor with experience as an auditor in the medical devices, in-vitro diagnostics, or pharmaceutical industry preferred.
• Strong working knowledge of standards, regulatory requirements, standards, and quality management systems for medical devices:
o US FDA (21CFR parts 820 / 801 / 803 / 806)
o European MDR and IVDR
o ISO 13485 / ISO 9001 / ISO 14971 / ISO 19011 /ISO 27001/ IEC 62304 / IEC 62366
o MDSAP Audit methodology
o Canadian Medical Device Regulations (CMDR)
o Australia Therapeutic Goods Act
o Taiwan Pal– Taiwanese Medical Device Regulation
o Japan MHLW Ministerial Ordinance No.169
o Brazil ANVISA Good Manufacturing Practices
o Chinese Regulations
• Experience working with regulating authorities (e.g., US Food and Drug Administration)
• Ability to lead audit teams in an international setting to generate high-quality output on schedule and within budget
• Ability to oversee multiple audits concurrently, often with competing needs and deadlines
• Excellent people management and leadership skills, conflict resolution, assertiveness, negotiation, and influence management
• Excellent written and verbal communication skills
• Fluent in English (written and spoken). Additional languages a plus
• Willingness to travel based on audit needs