Participate in the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
Support and carry out quality initiatives program to address system inadequacies this may include quality programs, tracking, analyzing, reporting and problem solving.
Build quality into products through active participation with cross functional team projects to supporting product release.
Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.
Provide management with quality data and trends in product performance in meeting customer requirements by providing and monitoring of:
a) Product quality trend and address product issues.
b) Work with cross functional in evaluation and qualification of material and processes.
Ensure that systems and procedures are in compliance with ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820 and OHSAS 18001 requirement.
Participate in quality escalation issues.
Chair PQT quality related meeting and provide timely updates to stakeholders.
Evaluate product return and drive failure investigation.
Support plant-wide activities and special projects, as assigned.
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