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Senior Quality Engineer

Palo Alto, CA
  • Posted: January 23, 2023
  • Full-Time
Job Summary

The Senior Quality Engineer is responsible for taking the lead in establishing, implementing and

maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to US FDA, ISO 13485, and applicable International Quality Management System requirements. The Senior Quality Engineer will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Design History File, Training, Supplier Qualification, New Product Introduction, Complaints, and Corrective/Preventative Action.

Essential Job Functions
  • The Senior Quality Engineer will be innovative, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
  • Takes the lead of implementing standard approaches to problem solving and prevention. Devises creative approaches to solving problems encountered.
  • Ensuring compliance with Quality System requirements for all new product development as well as product modifications.
  • Review/approve product and QMS related documents on behalf of QA.
  • Partner with R&D and Operations in the development of verification and validation protocols for product designs and commercial releases.
  • Oversee Risk Management activities including Hazard Analysis, Failure Mode, Effects Analysis, and Traceability Analysis.
  • Maintain Risk Management documents throughout the product life cycle.
  • Manage the Corrective and Preventive Action process.
  • Identify, plan and participate in the implementation of process improvements.
  • Support non-product software validation activities.
  • Support supplier qualification and monitoring.
  • Review complex complaints and complaint trends, and oversee failure investigations.
  • Support development and continuous improvement of quality system procedures.
  • Report to management on quality issues and trends.
  • Available to be on calls in the morning or evening with global contract suppliers in other time zones.

  • BS or MS degree in Mechanical/Electrical/Industrial Engineering.
  • At least 5 years of experience working within the Quality organization of a Software Medical Device manufacturer.
  • Experience in software lifecycle processes, familiar with software code review and verification methods.
  • Knowledgeable in 21 CFR 820 (Quality System Regulations) and ISO 13485 is a must
  • Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen.
  • Experience working with strategic suppliers.
  • Experience with product lifecycle management (P/N creation, BOM creation, Document Change Control generation and management, Approved Supplier management, etc).
  • Quality engineering background and experience inspections, supplier qualifications and audits.

  • Ability to travel 10% domestically and internationally as needed.
  • Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable.
  • Must be detail-oriented with strong written and oral communication skills.
  • Excellent written and verbal communication

Other Information
  • Job type: Full-time.
  • U.S. citizens, green card holders, and those authorized to work in the U.S. for any employer will be considered
  • Must be willing to work at our Palo Alto, CA location.



Palo Alto, CA
94309 USA



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