Quality Professional

4 days ago

Bengaluru, India Siemens Healthineers Full time

**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

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