QA-QC TEAM LEADER

Duties and Responsibilities:Monitor and checking processes according to ARKRAY’s policies, procedures and standards.Participate in CAPA Root Cause Analysis and Continuous Improvement Activities.Ensure product meets specification requirements by analyzing test results for applicability, accuracy documenting required data/information.Ensure CAPA/audit observations response are appropriately implemented and closed in a timely manner.During audit and inspections, provides general support to quality team.Assists with the creation, review and improvement of documentation.Qualifications:Preferably with Bachelor's College Degree.With at least three years of equivalent experience in a manufacturing set-up preferably in an ISO 13485 certified company.Qualified auditor or has experience with QMS Audits.Preferably with experience in US FDA audits handling.Ability to write QMS procedures and can judge suitability of working instructions and procedures.

ARKRAY Industry, Inc. always focus on providing new value to our customers and this is based on our founder’s drive for taking on challenges. This drive has been key over the years as we built up our own, rare business style and maintained a comprehensive approach to the development, manufacture and distribution of the sample test devices, diagnostic reagents and diagnostic support tools needed for clinical testing.