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Principal Quality Engineer

Thousand Oaks, CA
Top 3 Must Have Skill Sets:     
  • Experience with digital devices, health technology, products, mobile medical apps,
  • Deep experience with software medical device quality and compliance concepts
  • Strong project management skills / ability to lead and/or lead all aspects of numerous projects simultaneously
Day to Day Responsibilities: 
  • Represent Quality on cross-functional digital health and software medical device program/project
  • teams. Guide teams and ensure design controls and other regulatory/procedural requirements are
  • met.
  • Manage (or perform) audits / inspections / quality agreements (purchasing controls)
  • Participate in design reviews held by device manufacturers
  • Participate in supplier selection activities
  • Participate in project technical team meetings
Summary
  • Accountable to ensure quality and compliance associated with Amgen software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches.
Key Responsibilities
  • Benchmark with industry regarding quality and compliance models for software medical devices and digital health products
  • Accommodate Agile software development methodology
  • Ensure inspection readiness and maintain CE marks for existing software medical devices
  • Train and mentor relevant staff for development and succession planning
  • Maintain and resource program and project quality support portfolio
  • Collaborate with Senior Management, data management and presentation, provide backup support to other Quality focus areas
  • Work in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business
  • Plan and lead all aspects of major change efforts in the digital health space
Authority
  • Assure that current regulatory trends are accommodated in the capability
  • Advise software medical device and digital health product teams as Quality representative
  • Review and approve medical device design control and post-commercial documentation (internally and at times, externally)
  • Interface with regulators and Notified Bodies
  • Review and approve procedures and work instructions

Basic Qualifications:
Doctorate degree and 2 of professional experience Program Management, Operational Excellence, Quality, R&D, Production
OR
Master’s degree and 6 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
OR
Bachelor’s degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
OR
Associate’s degree and 10 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production
OR
High school diploma / GED and 12 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production 
 
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