Siemens Careers

Business Process Eng Spec 3

Cary, North Carolina
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Quality & Technology
Requisition Number: 226760
Primary Location: United States-North Carolina-Cary
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%

Division Description:

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Job Description:

·         Provides Quality Support to SHS AM NAM Services Department; Customer Services (CS), Digital Services (DS), and Enterprise Services (ES).

·         Performs intermediate areas of work for the professional field. Works independently to manage multiple projects, communicate updates, and meet milestones in a timely fashion.

·         Drives improvement activities to ensure compliance to Quality System Regulation 21 CFR 820, ISO 9001:2015, and Siemens internal policies and procedures.  

·         Independently performs important areas of standard professional level work that typically requires processing and interpreting, high-level complex issues. Identifies and resolves readily identifiable, clearly-defined problems

·         Participates in analysis of complex methods to promote effective operations through standardization, improvement, simplification, discontinuance, or other methods.

·         Participates in cross-functional teams to drive improvement in global processes that impact Healthineers Americas NAM compliance to regulations. 

·         Participates and or supports Quality management in recommending business processes that ensure alignment with strategic direction; integrates business processes between multiple organizations. .

·         Coordinates, maintains and drives Quality Metrics and activities through collaboration.

·         Leads and/or participates in internal audits and supports business process owners on external audit activities.

·         Leads efforts to maintain internal Quality initiatives through collaboration with respective organizational teams.

·         Engages in Quality Process training to ensure communication and knowledge of processes are standardized practice.

·         Coordinating with Siemens Healthineers QT and BA/BLs as necessary to insure the above.

 

 

Required Education:

 

·         BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.

 

Preferred Knowledge/Skills:

        

Demonstrates knowledge of Quality Management Systems and can apply lean principles effectively.

ISO 9001:2015 experience and Six Sigma Green Belt or Lean Certification a plus.

       Additional Regulatory experience a plus: 21 Part 820, Part 11, Part 803, and Part 806.

        Possess excellent problem solving, interpersonal communication, presentation and project management skills. 5-8 years of experience supporting customer facing organizations required demonstrating ability to successfully integrate multiple quality systems. Experience escorting FDA investigations and ISO audits strongly desired and CQA preferred  

·         Define amount of travel required with the position

    • 15% Domestic travel


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