Quality Professional - Auditor

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 Organization: Siemens Healthineers Company: Siemens Healthcare Private Limited Experience Level: Experienced Professional Full / Part time: Part-time