Siemens Staff Quality Engineer in Hoffman Estates, Illinois
Staff Quality Engineer
Locations:Hoffman Estates, Illinois
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 201460
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
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.
Molecular Imaging Division of Siemens Healthcare is looking for someone to join our team as a Staff Quality Engineer!
The Staff Quality Engineer will report to Sr. Management of Quality Engineering in either the Hoffman Estates (Chicago area) facility or the Knoxville facility. As a member of a cross-functional team with other business and engineering disciplines, the Quality Engineer ensures that Molecular Imaging products continue to meet or exceed customer requirements and that organizational quality objectives are satisfied which are consistent with regulatory requirements and business objectives.
The Quality Engineer is responsible for quality engineering activities through participation in the product development phase through commercialization and sustaining. Work scope of this position includes Quality Engineering support for design control, change processes and manufacturing support.
Typical job tasks for the Staff Quality Engineer include:
• Reviewing and approving product changes
• Representing Quality Assurance in product development project teams
• Participating in PFMEA activities with manufacturing engineers
• Participating in Product Risk Management activities
• Participating in Complaint Review Boards
• Driving process improvements to improve efficiency and quality
• Providing guidance and training support on quality-related topics to professional staff
• Analyzing production and quality trend data to identify and solve problems
• Conducting audits to determine acceptability of quality controls
Required Knowledge/Skills, Education, and Experience
• 8 to 10 years of successful work experience in quality discipline or related field in the medical device or biotechnology industry
• Limited travel 20%
• BS in an Engineering or Life Sciences field preferred with successful demonstration of key responsibilities and job knowledge
• Knowledge of FDA Quality System Regulation (QSR); ISO 13485; ISO 14971
• Experience participating in multifunctional teams
• Competent with Microsoft Office suite (Excel, Word, Outlook, etc.)
• Possess an attention to detail
• Eagerness to assist internal and external customers
Preferred Knowledge/Skills, Education, and Experience
• Working knowledge of quality system requirements for a medical device company with product development and production focus
• Successful work experience of 8 to10 years in Quality field
• Background in LEAN manufacturing principles
• ISO 13485 quality system experience
• Exposure with FDA and/or notified body audits
• ASQ Certified Quality Auditor (CQA) certification is a plus
• ASQ Certified Quality Engineer (CQE) certification is desired, though not a requirement
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 .