Siemens Design Quality Engineer in Tarrytown, New York
Design Quality Engineer
Locations:Tarrytown, New York
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 200416
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 10%
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/healthineers
Serves as Subject Matter Expert for application of Design Controls in accordance to regulatory expectations
Leads effective deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
Utilize quality engineering principles and problem solving skills (risk analysis, problem solving methodologies, statistical techniques, etc.) to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
Provides guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD, ISO standards, etc.)
Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
Ensure the development and validation of appropriate test methods for product and process performance
Ensure active and thorough investigation of quality issues and effective corrective and/or preventive action
Effectively utilizes Lean and Six Sigma methodologies as appropriate to achieve optimal results
Participates as subject matter expert during regulatory inspections
Job Family Responsibilities:
This position is responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. As a Subject Matter Expert (SME), the individual must be able to lead improvement projects and training on any of the elements within Design Controls.
At a minimum, a BA/BS degree (in a Life Science, Engineering, or Physical Science preferred).
Certifications, Licenses, Registrations:
Certified Quality Engineer (ASQ CQE, CRE or equivalent) preferred
Green Belt or Black Belt certification preferred
Knowledge and Experience:
Demonstrated comprehensive knowledge of field of specialization to support the successful completion of complex assignments. This includes in-depth knowledge of ISO 13485, and FDA Quality System Regulations. Typically 8-10 years of successful experience in related field and successful demonstration of Key Responsibilities.
Direction of Others:
This is an individual contributor role. The DQE 5 provides specialized direction to professional counterparts on teams. Leadership qualities and role model qualities demonstrated.
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 .