Siemens Careers

Supplier Quality Engineer - IVD/ Medical Device

Berkeley, California
Quality Management

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English (US)

Job Description

Division: Siemens Healthineers
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%

Division Description:

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


Job Description:

Specific Requirements
Position Overview

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. 

Responsibilities

• Lead the supplier quality activities associated with the Business Unit, with a focus on supplier selection, qualification, audits, and supplier corrective actions (SCARS)
• Lead process improvement activities, to ensure a best-in-class supplier management
• Be a leader in introducing and coordinating improvements through training, coaching, new quality tool implementation, and authoring or editing standard operating procedures.
• Execute supplier audit process, including scheduling, conducting, and reporting.
• Oversee and Execute Supplier Corrective Action Request (SCAR) process, by consolidating SCAR metrics for regular review, and driving actions with suppliers.
• Facilitates cross-functional communication to foster alignment in managing suppliers
• Support the CAPA program for the Business by participating in CAPAs, where appropriate
• Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits as a member of the Siemens quality management team.
• Participate and collaborate with employees in a global company to ensure QMS compliance and align local SOP’s as required with common Business Unit SOP’s.
• Guides and/or mediates the decision making process on project and deliverable execution
• 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
• 6+ years’ experience in a quality assurance role at a medical device manufacturer or supplier
• First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements, with a focus on: supplier/purchasing controls, nonconformance, corrective and preventive action
• Lead auditor training (ISO 13485, or 14971) and 2+ years experience in conducting supplier audits
• Driven individual with a history of developing collaborative, cross-functional solutions
• Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
• 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
• 8+ years’ experience in a supplier quality assurance role at a medical device or IVD Manufacturer
• Prior experience in implementing new procedures, processes, and tools for supplier management
• Prior experience in in-vitro diagnostics highly preferred
• Prior experience managing a supplier audit program (planning, scheduling, conducting, and reporting)
• Prior experience with managing a CAPA and/or SCAR program
 
 
 


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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.



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