Siemens Quality Engineer III in Hoffman Estates, Illinois
Quality Engineer III
Locations:Hoffman Estates, Illinois
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Diagnostic Imaging
Requisition Number: 224955
Primary Location: United States-Illinois-Hoffman Estates
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 20%
At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.
Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.
The Molecular Imaging Division of Siemens Healthcare is looking for someone to join our team as a Quality Engineer 3.
The Quality Engineer 3 will report to the Sr. Manager of Quality Engineering in the Hoffman Estates (Chicago area) 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 Quality Engineer 3 include:
· Manage and approve Engineering Change Orders
· Representing Quality Assurance in product development project teams
· Support product risk management activities, CAPA, and internal audit processes
· 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
· Provide day to production support including providing guidance on PFMEA, process validation, and process qualifications
· Initiate and release quality holds as necessary
Required Knowledge/Skills, Education, and Experience
· 5 to 8 years of successful work experience in quality discipline or related field in the medical device or biotechnology industry
· Travel up to 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
· Successful work experience of 5 to 8 years in Quality field
· Working knowledge of quality system requirements for a medical device company with product development focus
· 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/pay-transp_formattedESQA508c.pdf .