Associate Quality Engineer

Biolase Technology, Inc. Irvine , CA 92606

Posted 2 months ago

Position is responsible for supporting all aspects of the Quality Assurance Program, including internal/external quality issue resolution, supplier quality issues, supplier audits, CAPA's, Customer Complaint Analysis, to drive product and process improvements.

This involves providing statistical information for quality improvements by identifying testing methods and sampling through the use of various statistical tools.

This position is granted the authority by the Director of Quality to take any actions required to fulfill the scope, duties and responsibilities of this position.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Provide root cause analysis support and drive the implementation of corrective actions

  • Interface with Engineering and Operations to ensure transfer to production of new products meeting all quality system requirements

  • Provide guidance to production and quality assurance on the use of statistical tools, i.e. SPC, Sampling Methods, and Gage R&R Studies

  • Conduct Supplier Audits and follow-up on any open corrective actions

  • Participate in complaint investigations, failure analysis of returned products and production issues

  • Provide support for continuous improvement of the quality management systems

  • Work with Manufacturing to coordinate and monitor production processes to ensure compliance to FDA QSR, ISO 13485

  • Write software validation protocols and reports for new and revised software applications

  • Write process validation protocols and reports for new and improved manufacturing processes

  • Develop sampling plans by applying attribute, variable and sequential sampling methods

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Associate Quality Engineer

Biolase Technology, Inc.