Global Process and Quality Specialist ESM (186853)

Job Description

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

Competencies required:

    • 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

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

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