Job Description
Hi
We have an immediate requirement for Software Quality Engineer. If you are looking for new job roles, please share your updated resume or you can reach me on +1 732 338 7842
SOFTWARE QUALITY ENGINEER
REMOTE LOCATION: THOUSAND OAKS, CA
START TO FINISH 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
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