Methodical, analytical, and results-driven professional, offering comprehensive experience in quality, regulatory compliance, and project management within the medical device and healthcare industries. Demonstrate strong knowledge of corrective and preventive actions, internal audit program, post-market surveillance, cost control, orders fulfillment, and sales revenue development. Possess solid work ethic in accomplishing duties and responsibilities to attain company goals and objectives. Exhibit exceptional interpersonal and communication skills in cultivating relationships with professionals of diverse cultural levels.
Oversee the corrective and preventive actions (CAPA) and internal audit programs, which include direct reporting of key performance indicators (KPIs) to the Senior Management Team.
Lead process improvement initiatives focusing on Lean and regulatory compliance requirements.
Function as lead internal auditor for ISO13485:2003 and 2016, 21CFR820, and MDSAP audits.
Audit readiness compliance manager for the Assembly and Test Production Department.
Act as Q&R Lead during Notified Body Audits.
Guide cross-functional teams to implement solutions in improving supplier quality, procurement, customer service, and operations.
Conduct QMS projects, which include the implementation of the Unique Device Identifier (UDI) control and labeling.
Assume accountability in controlling and managing QMS site-wide records.
Effectively direct Kaizen events for production operations.
Create and facilitate QMS training sessions, as well as devise a good documentation practices program for device history records.
Execute revised Process Validation Program, including IQ, OQ, and PQ process redefinition.
Define and implement SAP solutions for regulatory control of medical device sales.
Improved and sustained CAPA completion timeliness to more than 90% by leading multi-disciplinary teams using Project Management principles.
Served as the person behind the implementation of a fully compliant UDI labeling for medical devices
Played a key role in consistently passing all regulatory audits with no major findings
Successfully completed a project to control Technical Data Kits which was on time and within budget.
Completed numerous technical Procedure Writing Projects for Q&R and Operations Department.