Quality Assurance Management

Tom Nguyen

** ***** ******

RSM CA *****

Cell: 949-***-****

Email: ad5klx@r.postjobfree.com

Objective:

Results-oriented quality professional with extensive experience in computing, networking, and laboratory safety testing seeking to leverage expertise in quality management, team leadership, and process improvement in a dynamic environment.

Professional Experience:

Project Quality Leader (PQL) / QE II (Nov. 2014 to Feb. 2022)

Schneider Electric - Triconex 26561 Rancho Pkwy S Lake Forest, CA 92630

Responsible for leading the development and implementation of local ISO 9001 quality management system and measures to ensure consistency and adherence to ISO 9001 / IEC 61508 FS / NQA-1 standards and requirements related to the Triconex brand product line.

Coordinated with various departments to establish ISO 9001 QMS compliant procedures, test specifications, standards and systems.

Conducted regular audits, identified areas of non-compliance, and implemented corrective actions.

Key stakeholder responsible for leading the project development and production teams to meet market demand in a dynamic working environment.

Worked closely with the QAU to help promote a culture of continuous improvement and lean management.

Reviewed customer, product and purchase order requirements and ensured respective standards and regulatory requirements were met.

Worked closely with the Leadership team and company staff to establish product quality and customer requirements.

Monitored key product quality performance metrics by gathering relevant data and producing statistical reports for monthly reporting to the Leadership team.

Organized and helped managed quality assurance functions in close cooperation with R&D and Project Development teams to ensure customer and product requirements are met in accordance with local standard operating procedures.

Quality Assurance Auditor (Jan. 2009 to Nov. 2014)

North American Science Associates (NAMSA) 9 Morgan Irvine CA 92618

Responsible for ensuring policies, procedures and requirements are followed in accordance with ISO 13485 / FDA GLP requirements / 21 CFR related to medical device testing for FDA market approval.

Worked closely with top management to ensure conformance of the QMS and

processes to drive improvement and provided recommendations for areas of improvement.

Provided quality support for onsite client, FDA, ISO and TUV audits.

Worked with Quality team to manage the CAPA process via nonconformance reporting, root cause

analysis, failure mode investigations, unexpected testing investigations.

Conducted quality review of nonclinical medical device safety test data submitted by Metrology, Microbiology, Chemistry and Invitro/ Invivo Toxicology.

Reviewed engineering protocols, performed M&TE qualifications, validations and calibration events.

Responsible for performing quality audits, including internal quality system compliance audits

Conducted GLP/GMP audits and reporting

Responsible for document control approval of Test Specifications, SOP’s, Engineering Validations and GLP Protocols

Managed quality performance metrics for the Irvine location on a monthly basis, as delegated.

Helped improve overall quality performance indicators through the effective use of failure mode investigations and effective CAPA plans.

Provided recommendations for corrective and preventative action plans.

Performed M&TE Calibrations and IQ/OQ/PQ Equipment Validations

Worked with Calibration House to ensure monthly calibration triggers are completed.

Created purchase requisitions for external suppliers and lab equipment.

Invitro Technologist (2003 to 2009)

North American Science Associates (NAMSA) 9 Morgan Irvine CA 92618

Performed various USP safety tests in the Invitro model according to the test protocol, requirements and specifications.

Monitored laboratory test equipment and environment for OOS excursions, with reporting.

Assisted team with in process validation and calibration activities.

Performed Cytotoxicity testing of sponsor test articles.

Tracked statistical data for LAL testing and conducted OOS Failure Investigations and CAPAs.

Followed written SOPs, test specifications, and protocols.

Associate Research Professional (2002 to 2003)

Allergan Pharmaceuticals 2625 Dupont Drive Irvine, CA 92618

Conducted GLP testing in the Invivo model and measured cMAP effects following dosing of Botox.

Supported Study Director with the review of GLP study data and final report review.

Maintained laboratory notebook of all testing activities and study records.

Performed lab equipment calibrations and validation activities.

Ensured all governing procedures were followed per SOP and FDA regulations.

Education:

Whittier College, Whittier CA

B.A. Class of 1995

Major: Biology Minor : Psychology

Skillset:

Hard Skills:

- Quality Management

- ISO 9001 QMS

- ISO 13485 Medical Device Directive

- FDA 21 CFR

-TUV IEC 61508 Functional Safety

- Computer Networking

- Microsoft Certified Profesional

- Statistical Analysis

Soft Skills:

- Leadership

- Communication

- Problem-Solving

- Team Building & Brainstorming

- Continuous Improvement

- Customer Service & Quality Excellence

Certifications:

MICROSOFT CERTIFIED PROFESSIONAL (MCP)

FDA Risk Management

NQA-1

MICROSOFT Certified Network Specialist (CNS)

Lean Six Sigma Green Belt (Schneider Electric)

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