Siemens Quality Engineer 4 in Cary, North Carolina
Quality Engineer 4
Locations:Cary, North Carolina
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Quality & Technology
Requisition Number: 201074
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 50%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthcare
Quality Engineer- Located in Cary NC reporting to the Director of Quality for HC NAM USA
· Performs advanced areas of work for the professional field.Able to manage multiple projects, communicate updates, and meet milestones in a timely fashion. Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.
· Drives improvement activities to ensure compliance to Quality System Regulation 21 CFR 820 and Siemens internal policies and procedures.
· Supports and improves the NAM USA Supplier Management quality elements for our suppliers and business partners. This position would be responsible for supporting the requirements of our MES program, coordinating with global SQM and ES
· Implement requirements for all NAM USA suppliers, qualifying suppliers per set requirements prior to supplier selection, auditing suppliers, developing quality metrics for suppliers, rating vendors based on quality metrics, perform annual vendor surveys, drive and coordinate supplier corrective actions, participate in supplier development, review supplier contracts to ensure proper quality requirements are specified.
· Supports internal NAM USA organizations (e.g. Service, Sales) to ensure their compliance to the FDA QSR and Siemens policies and procedures
· Leads/ participates in cross-functional (Healthcare wide) teams to drive improvement in global processes that impact NAM USA compliance to regulations
· Develops documentation (Policies, SOP's, Work Instructions, and Training) to support and drive the development and improvement of NAM USA Quality Systems
· Leads or participates in compliance inspections and audits for monitoring the compliance of NAM USA and external support organizations (e.g. suppliers, RU and business partner facilities) according to FDA QSR and Siemens' policies and procedures.
· Coordinating with Siemens Healthineers BA/BLs as necessary to insure the above.
Required Knowledge/Skills, Education, and Experience:
- BS/BA in related discipline. Typically 5-7 years of successful experience in a directly related field and successful demonstration of Key Responsibilities and Knowledge5 years experience with FDA Medical Device or IVDD regulations in a Quality Systems role required.Proven ability to work independently and in groups. Knowledge of supplier management; possess strong level of organizational skills. LeadAuditorcertification strongly desired (ISO, QSR)
· 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 CQE preferred
· Define amount of travel required with the position
- 40% 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 at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/PayTransparencyNotice_JRFQA508c.pdf .