Siemens Careers

Business Process Eng Spec 3

Cary, North Carolina
Quality Management

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:


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

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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.