Dynamic Quality Administrator with extensive experience at GCM Medical, skilled in High QA software and ISO 9001:2015 , ISO 13485:2016 and AS9100D internal auditing. Proven track record in optimizing quality processes and enhancing team communication. Adept at managing nonconformances and ensuring compliance, while fostering a collaborative work environment. Committed to continuous improvement and quality excellence.
Overview
24
24
years of professional experience
Work History
Quality Administrator
GCM Medical (formerly Precision Swiss Products)
01.2022 - Current
Responsible for the creation and monitoring of the inspection documentation utilizing High QA software. This includes ballooning all drawings, creating and updating of inspection plans, documents such as First Article Reports (FAIRs), Statistical Process Control (SPCs) and Quality Inspection Work Instructions.
Responsible for pulling inspection information during and post manufacturing to create the shipping documentation package, processing an order to inventory in order to ship, as well as completing a thorough audit of the ERP system data to ensure quantities and log in's are all complete and traceability adds up.
Responsible for monitoring nonconformances including internal, customer and vendor nonconformances. This also includes issuing RMA, assisting with determining root causes, corrective actions, and preventative actions as needed. Ensuring the timely completion and record keeping of all nonconformances. Evaluate effectiveness of these activities.
Conduct internal audits per audit schedule. Includes review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan.
Monitor the Approved Vendor List (AVL). Assist with sending and receiving Supplier Quality Documentation. Liaise with suppliers in addressing nonconformances through thorough investigations. Issue Vendor Return as needed. Assist in assessing to determine appropriateness of corrective/preventative actions to avoid reoccurrence.
Optimized internal communication channels, ensuring clear reporting of quality metrics and progress towards goals.
Wafer Fab Manufacturing OPerator
Western Digital Corporation
01.2016 - 12.2021
Operated Metrology measurement and imaging such as Photo, FIB and STEM equipment safely with team of operators.
Trained new employees on company policies, equipment operation, and best practices, fostering a positive work environment and team cohesion.
Set up and ran machinery to produce exceptional products for industrial needs.
Inspected products and machines to maintain quality and efficiency.
QA/QC Specialist, Lead
Supertex, Inc.
11.2000 - 04.2015
Performed functions in the application of basic Quality System principles such as Document Control, Incoming Quality Control, Final Product clearance, Calibration, Internal Process Audit, Nonconforming Material, RMA and Complaints management.
Responsible for maintaining Quality records. This includes monitoring and maintaining Tool Calibration records. Periodically review and update work instructions as needed.
Conduct periodic Internal Process Audit to ensure compliance to Regulatory standards such as ISO9001, ISO/TS16949 and ISO 14001. Includes issuing and follow up of Corrective Action Request (CARs). Collaborate with vendors/suppliers regarding quality issues.
Performed mechanical testing such as Physical Dimension, Solderability and Mark Permanency Test.
Education
Bachelor of Arts - Behavioral Sciences
University of Santo Tomas
Manila, Philippines
03-1984
Skills
High QA Software Certified: Basic, Advanced, Job and Sample Planning, Inspection Planning, PPAP with PQP
ISO 9001:2015 internal auditor certification
ISO 13485:2016 and AS9100D Internal Auditor Training
Internal auditing for compliance
Assist/Host External Audit
Evaluate traveler packets for DHR retention
Manage MRB activities
Shipping document review and approval
Aid in quality assurance inspections through Keyence tools
Experienced in Microsoft Office applications
Coordinating multiple functions including shipping and customer service
Languages
English
Full Professional
Timeline
Quality Administrator
GCM Medical (formerly Precision Swiss Products)
01.2022 - Current
Wafer Fab Manufacturing OPerator
Western Digital Corporation
01.2016 - 12.2021
QA/QC Specialist, Lead
Supertex, Inc.
11.2000 - 04.2015
Bachelor of Arts - Behavioral Sciences
University of Santo Tomas
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