Supplier Quality Engineer - IVD/ Medical Device
Business Unit: Strategy & Innovation
Requisition Number: 231032
Primary Location: United States-California-Berkeley
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.
For more information, please visit: http://www.usa.siemens.com/healthineers
The open position is for a level 4 Quality Engineer within the Quality Management team for Molecular products located in Berkeley, CA. The successful candidate will be responsible for supplier quality management for the business. The successful candidate will be responsible for providing quality expertise and oversight in qualifying, auditing, and monitoring suppliers to ensure compliance with internal procedures and regulatory requirements for in-vitro diagnostics and medical devices. Applicable topics or deliverables include supplier qualifications, supplier evaluations, supplier audits (planning, fieldwork, reporting, follow-up), supplier agreements, quality assurance agreements, supplier metrics, supplier nonconformances, complaints, supplier corrective actions, and CAPAs. In addition, the successful candidate will support product development, product change, and other internal projects as they impact suppliers and participate in internal and external audits. The successful candidate will report in to the Manager of Quality Engineering within the business. Must be able to work independently, interface effectively, and demonstrate a high level of reliability, integrity, and personal accountability, as a member of the Siemens quality management team.
• Lead the supplier quality activities associated with the Business Unit, with a focus on supplier selection, qualification, audits, and supplier corrective actions (SCARS)
• Reviews and approves documentation for compliance with US, EU, and other international regulations
• Identifies and manages areas of potential noncompliance
Required Knowledge/Skills, Education, and Experience
• Minimum BA/BS in scientific discipline
• 10-20% travel required
• Working knowledge of common computer software applications (Word, Excel, Powerpoint, Adobe Acrobat, etc)
Preferred Knowledge/Skills, Education, and Experience
• BS degree in Engineering, Molecular Biology or Biochemistry preferred
• Prior experience in implementing new procedures, processes, and tools for supplier management