Job Description
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:
oUS FDA (21CFR parts 820 / 801 / 803 / 806)
oEuropean MDR and IVDR
oISO 13485 / ISO 9001 / ISO 14971 / ISO 19011 /ISO 27001/ IEC 62304 / IEC 62366
oMDSAP Audit methodology
oCanadian Medical Device Regulations (CMDR)
oAustralia Therapeutic Goods Act
oTaiwan Pal– Taiwanese Medical Device Regulation
oJapan MHLW Ministerial Ordinance No.169
oBrazil ANVISA Good Manufacturing Practices
oChinese 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
