Quality Professional - Bengaluru, India - Siemens Healthineers

Siemens Healthineers

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

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, invitro diagnostics, or pharmaceutical industry preferred.
Strong working knowledge of standards, regulatory requirements, standards, and quality management systems for medical devices:
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 6236- 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.16- 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 highquality 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