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
Biolase Technology, Inc.