About this role
1.Responsible for improving current QMS procedures in conformity to regulatory requirements from FDA QSR (21 CFR Part 820), ISO 13485 and GMP. 2.Collaborate with Design & Development functions to ensure qualified documentation of DHF and DMR. 3.Collaborate with Manufacturing functions to establish and implement procedures related to production quality control. 4.Lead routine validation, re-validation and monitoring activities including but not limited to manufacturing processes such as EO sterilization, packaging, and facility maintenance such as equipment, cleanroom HVAC, and bio-burden monitoring. 5.Participate in external quality inspections and execute internal and supplier audits. 6.Participate in risk management activities throughout product life cycle and generate required documents and records.