Responsibilities

• 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