Tasks and Responsibilities
-Quality and process support for the Education and Skills Management (ESM) segment of the Education Business with a global scope.
-Provide guidance and support to ESM product owners to fulfill commercialization process and quality requirements (purple book and green book process).
-Ensure that all quality and audit relevant documents are prepared and filed and relevant process milestones are fulfilled.
-Review all Q documents relevant to the ESM portfolio.
-Advice and support to the ESM team before, during and after audit events and managing of all activities related to audit preparation and completion
-Troubleshoot process problems and make recommendations for improvement (CAPAs, issues from other depts., etc.) Determine root cause, create action plans, communicate, train and verify effectiveness.
-Trains associates on process changes as needed
-Facilitates process oriented Workshops
- Minimum # of 5 Years Experience
- Must have Required Experience in Quality
processes in Healthcare industry, experience with Siemens CS Green Book
and Purple Book
- Understanding of quality requirements at Healthcare (ISO 13485, ISO 20001, ISO 27001, 21 CFR Part 820, Chinese SFDA req.)
- Understanding of Green Book and Purple Book process description
- Understanding of SIPEX/Healthcare process house and of CS processes and –descriptions
- Standardization and continuous improvements of work methods in the IMS process
- Self prioritization of projects and tasks under changing job requirements, high flexibility
- Self-motivated project management
- Excellent analytic skills, organizational and quality orientation
- Strong process and change management skills across functions
- Focusing on results with orientation on organization and quality
- Strong collaboration, influencing and coaching on different management levels
- Customer focus and orientation
- Knowledge and experience of Siemens Healthcare business and products
- Knowledge of current QM methods and IT tools
- Fluent in English
- Strong intercultural sensitivity and collaboration
This position requires the ability to interact with multiple levels of people and management.
Key partners/collaborators include: all EDU Business Development and ESM employees, counterparts within the RHQ AM, CS HQ EDU and CS CRM in Erlangen and other countries worldwide
Job ID: 186853
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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