• Reviewed production, testing, and related documents and results and prepare required documents for product release.• Build and maintained positive relationships within all levels of the organization.• Sampled, inspected and measured in‐process and finished devices according to applicable quality control specifications and procedures• Managed the development and implementation of QC test equipment calibration and maintenance program• Maintained and finalized report of CAPA, OOS, OOT and events.• Suggested the quality change to bring best quality product to the customers• Established testing procedures to determine product quality and document results• Developed and monitored project budgets and schedules• Participated in QMS audit programs to evaluate compliance to relevant standards, directives, regulations and policies• Participated in the maintenance of design history files and device master records• Drafted and implemented validation protocols and reports• Updated and maintained Quality System to ensure compliance with relevant standards and requirements• Ensured calibrations and preventative maintenance for all manufacturing equipment is up-to-date• Ensures that the department operates in full compliance with GMP, GLP, SOP, and established safety standards.• Reviewed and optimized processes and SOPs on a periodic basis to maximize efficiency.• Making and trained employees for SOP, WI, FORMS and organizational compliance with GMP and quality system

• Provide support for the initiation, timely investigation completion and closure of CAPAs in Track wise.• Review/Approve CAPA documentation for compliance with corporate requirements• Identify/Implement corrective and preventive actions and evaluate effectiveness• Track and trend CAPAs.• Initiate/Perform Quality Assessment/Track Change Control in Track wise • Review change control documentation for new service codes• Manage document change control process• Perform and document complaint investigation and perform complaints trending• Liaise with Product Surveillance to effectively process complaints o Manage the return of Complaint samples• Drafted and implemented validation protocols, reviewed validation results, and prepared summary reports • Reviewed, tracked and processed Standard Operating Procedures (SOP); • Developed and conducted Quality related training programs (e.g. cGMP, GDP, SOPs)• Assisted in completion of OOS, OOT, Events and CAPA investigations, and resolution of audit observations. Participate in and support plant projects and validations as required