Quality and Auditing Expert
We are seeking a seasoned professional with 6-10 years of experience in Quality and Auditing to join our team at Siemens Healthineers.
Key Responsibilities
1. Evaluate the IT Quality Management System (QMS) for compliance with applicable standards, including ISO 9001, ISO 27001, and guidance documents specific to the audit target. Knowledge of ISO 13485 and MDSAP is an advantage.
2. Act as a Lead Auditor and manage qualified audit teams during the audit process.
3. Develop, design, and execute IT audits and assessments based on the global internal audit plan and ad-hoc requirements, utilizing a risk-based approach.
4. Prepare and present reports on findings and recommendations to auditees and communicate results to senior management.
5. Serve as an expert on applicable regulatory requirements, their interpretation, and application, proposing and consulting on action plans for resolving identified gaps and risks.
6. Identify best practices and promote their adoption across the organization.
7. Accompany and support incoming audits/inspections, liaising with external auditors and counterparts in Business/Functions.
8. Consult on post-audit/assessment remediations.
Required Skills
1. Essential knowledge and long-time experience with ISO 9001, MDSAP, ISO 27001, and desired ISO 13485.
2. Strong problem identification and analytical skills.
3. Motivated self-starter who works well individually and is a team player.
4. Self-confident personality, experienced with communicating up to senior level management.