Job Family Specific Responsibilities/Key Responsibilities:
• Participates in Management system (Quality and or EH&S) projects. Includes: Implementing actions, monitoring effectiveness and verifying sustainability of process controls.
• Contributes to team effort to improve management system and operational processes. Proactively shares knowledge in a systematic way to grow know-how base of the IMS team.
• Supports the management of the training process and tool. Activities include but not limited to, support process owners with document updates, administration, Sharp ticket management and supporting the implementation of change control board actions, etc.
• Supports the CAPA process with CAPA tool support and Capa Review Board “Lite” administration.
• Supports Document Management process owner with document administration activities.
• Collaborates and ensures effective cooperation with both internal and external customers by clarifying issues and identifying risk mitigations actions.
• Manages routine and non-routine management system tasks such as ad hoc reporting, auditing, risk analysis, etc.
• Initiates actions according to guidelines, when processes or activities are not meeting standards, regulations or laws.
• Provides procedural writing support for integrated management system changes.
• May be required to respond to management system process related inquiries, in certain subject matters.
• May be required to support internal and external audits or inspections.
• BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas. Advanced degree MAY be substituted for experience, where applicable.
• Must have experience 5-7 years working within a regulated medical device industry.
• Must have 5-7 years of successful experience in an EHS and/or Quality role.
• Must have experience with process ownership of management system elements (i.e. managed processes and records relating to CAPA & Training).
• Demonstrates high professional judgment competence.
• Training/certification for ISO standards (9001 or 13485,14001,45001 )
Job ID: 193293
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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