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Sr. Quality Assurance Engineer

3 months ago

Irvine, United States PRISMATIK DENTALCRAFT, INC. Full time

Position at Prismatik Dentalcraft, a subsidiary of Glidewell

Essential Functions:

  • Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
  • Responsible for the administration of the QMS software.
  • Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
  • Integrates ISO 14971, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
  • Mentors and provides direction to software development teams in design controls and lead risk management activities.
  • Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
  • Provides CAPA, complaints, audit and overall QMS support in regards to software.
  • Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications:

  • Bachelors degree in Engineering, Biomedical, or related technical field or equivalent practical experience.
  • Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry.
  • Advance knowledge with development and test requirements with recognized standards (ISO 13485).
  • Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.