Quality Engineer 4
Business Unit: Diagnostic Imaging
Requisition Number: 235450
Primary Location: United States-Tennessee-Knoxville
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 Healthineers is looking for someone to join our team as a Staff Quality Engineer!
The Staff Quality Engineer will report to the Director of Quality and be located in Knoxville, TN 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; MDSAP
· 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