Contribute to maintaining and improving quality systems to ensure compliance with global regulatory requirements and assuring that the quality systems are used effectively to support company quality policy and objectives. Support the preliminary investigation on CAPA/QAR/audit findings, prepare and analyze reports/metrics, update procedures, and participate in facilitate Quality Systems related discussions. Drive activities related to Quality System improvements. Job duties:

Maintain CAPA process.

Partner with CAPA owners to investigate issues related to audit findings, CAPA, and QAR by collaborating with various functions (e.g., R&D, Production, Field Assurance, etc.). 

Facilitate CAPA Review Board meetings, prepare data to be analyzed for CAPAs, and follow up on actions to drive on-time delivery of committed actions. 

Lead and support CAPA owners in understanding and conveying problem statements, conducting thorough root cause investigations and analyses, p...