Quality Assurance Engineer

Gerson J. Salgado

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

Santa Ana, CA 92703

Mobile: 714-***-****

Email: ********************@******.***

OBJECTIVE: To acquire a challenging position as an associate in mechanical/quality Engineer, where my current skills and experience using the Quality Management System will help identify the correct process and measurements to assure that products always exceed quality standards.

EXPERIENCE SUMMARY: I possessed over 20 years of combined quality assurance and engineering experience and knowledge assisting Quality and Mechanical Engineers in the aerospace, pharmaceutical and medical fields.

EXPERIENCE:

Zio by iRhythm Technologies – Cypress, CA

May 2024 – Present

Quality Specialist – Post Marketing

Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.

Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.

Evaluate all information from a technical perspective to ensure appropriate Analysis and Investigation.

Reviews daily processes to ensure issues are being addressed and escalated in a timely manner.

Maintains complaints log.

Participate in process improvements.

Perform other quality and regulatory related duties as assigned.

B. Braun Pharmaceuticals - Irvine, CA

March 2022 - August 2023

Product- Mechanical Engineer

Perform investigations discrepancy notifications (DN's) and complete the write-ups, reports, to close the DN's.

Initiate and manage Corrective and Preventive Actions (CAPA's) and the management of change (MOC) programs for the department.

Analyzes existing equipment, processes, facilities, infrastructure, and systems to identify areas of improvement and recommend solutions to optimize performance.

Acts as a subject matter expert for designated systems/technologies and provide technical recommendations.

Anticipate potential process related problems, risks, and technical conflicts and develop the necessary contingency plans to improve business continuity.

Performs troubleshooting and modifications to the automated equipment adhering to pharmaceutical and medical devices Good Manufacturing Practices (GMP) change control standards and policies.

Creates and modifies systems specifications and standard operating procedures for the systems supporter.

Contributes to the development of continuous improvement to systems.

Water treatment operations; maintenance support for Water for Injection (WFI).

Material Review Board/ Corrective and Preventive Actions /Engineer Change Record/Engineer Change Notification & Installation Qualification, Operation Qualification, Performance Qualification Protocols.

Nihon Kohden - Irvine, CA

Oct 2021 - Jan 2022

Quality Assurance Engineer I

Responsible for processing global commercial/clinical product quality complaints while using Good Documentation Practices (GDP).

Interface with Customer Service, Field team, and customers to gather additional information required for complaint initiation/investigations.

Responsible for complaint handling process from initiation to Medical Device Regulation (MDR) & Incident Reporting, investigation and closure in a uniform and timely manner.

Conduct investigations and provide corrective and preventive actions and complaints based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements.

Conduct investigations and provide corrective and preventive actions and complaints based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements.

Assess incoming complaints and elevate potential issues/incidents to Quality Management/supervisor, including but not limited to, possible recall situations, remedial action, and field safety actions.

Evaluate complaints to determine whether an investigation is necessary and if it is possible for an adverse event/malfunction report may need to be filed in accordance with applicable regulation and company procedures.

Review compliant files for completeness and follow-up with suppliers (responsible party) for investigation outcomes.

Work closely with Manufacturing/Operations, R&D and other departments to ensure quality products and processes are developed, deployed and meets US and OUS requirements. This includes hardware and software validation, risk analysis/FMEA, etc.

Utilize systems for the identification, analysis, correction, and prevention of quality issues.

Participate in CAPA Management, and other quality engineering projects as assigned.

Conduct and maintain complete complaint files and databases for all customer complaints per US engineering activities in compliance with FDA Regulations, ISO 13485 and other national and international quality and regulatory (as applicable) requirements and company procedures standards.

Establish & interact with customers verbally or in writing using clear, effective communication.

Facilitate the resolution of product issues in the field, through coordination of investigations, submitting and/or initiating corrective action requests, etc.

Prepare MedWatch reports and OUS incident reports (as applicable) for review, and finalize reports based on feedback from supervisor and/or designated medical professional and perform submission to applicable regulatory agencies.

Track and monitor the status of adverse event reports filing timelines to ensure all reports are submitted on-time and report weekly status or as instructed by supervisor.

Prepare customer notification letters for receipt of product complaint and follow-up acknowledgement letters information, as required.

Determines product and incident complaint codes to facilitate data trending and analysis review.

Coordinate with complaint investigation personnel to understand root cause in support of documenting proper complaint file closure.

Perform closure of all complaint files and ensure that all pertinent information is contained consistently and uniformly within the file prior to closure.

Complete all required customer complaint-related documentation in an accurate, professional and timely manner.

Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.

Research and compile reports for competent authorities and submit them for approval to supervisor/QA management.

Provide follow-up to internal and external customers needed, including customer correspondence and regulatory agency correspondence.

Prepare final correspondence summarizing investigation findings.

Prepare metric and status information on the complaint handling program as required.

Create, analyze, and provide feedback on complaint data for the team and management, as requested.

Gather data for post market surveillance activities and participate in projects as required.

Guide internal personnel on the complaint handling.

Assist as needed in the preparation of data for internal audits and external audits/inspections.

Participate in projects or other duties as assigned.

Adheres to all company policies, procedures and business ethics codes.

Phillips Medisize a Molex Company - Costa Mesa, CA

May 2017 - June 2020

Field Assurance Specialist

Coordinates with Customer Service on the receipt of customer returns.

Initiates Quality Notifications on SAP.

Initiates the 8D Complaint investigation of the customer complaint to verify reported complaint and to code the complaint within SAP Quality Notification database.

Work with Customer Service to communicate complaint investigation progress through the 8D reports.

Reports to customer service initial investigation results for the customer restitution associated with the complaint.

Initiates the 8D process for investigating the complaint.

Track and Trend Metrics for costumer’s complaints, includes open, closed and reporting to the customer (Trends reviewed at the Management Review Meetings).

Coordinates with QMS, SQE, & AQP on the receipt of customer returns.

Initiate Quality Assessment and Rework for Quality Notifications.

Report to the customer of our preliminary response to the complaint, including containment activities.

Update and maintain track and trend metrics.

Support Quality team on Quality Assessment.

Rework Quality Notifications.

Create projects for Management.

Report to the customers on our corrective action plans including closure.

Currently training on validations.

Root cause investigation, review DHR’s/Work Orders.

Create Gauge R&R ‘s and MSA’s.

Protocols & Reports.

DHR/Work order reviews.

Material Review Board/ Corrective and Preventive Actions.

Engineer Change Record/Engineer Change Notification process.

Installation Qualification, Operation Qualification, Performance Qualification Protocols.

Good Manufacturing Practice (GMP)/Standard Operating Procedures (SOP).

Incoming, in-process and final inspection.

Lot/batch number reviews.

C&D Zodiac Aerospace - Huntington Beach, CA

May 2016 to May 2017

Quality Assurance Inspector

Perform QA inspections and complete necessary reports using First Article Inspection Report (FAIR) of newly designed or revised products.

Read and interpret drawings, to adhere to company and costumer specifications.

Inspect incoming products and paperwork to ensure parts are in conformance to purchase order and engineering specification.

Perform inspection of parts manufactured in-house.

Inspect sub-assemblies used in the construction of aircraft interiors.

Mechanical/Visual inspection, assemble kits, loose parts.

Document control, receiving inspections and inventory list.

Utilize tools such as Calipers, Tape measure, Radius gages, Protractor, Micrometers, Multi-meter, digital height gages, comparators, pin gages, counter sink gauge.

Create Reports and Trend Analysis of incoming products to identify non-conformance parts.

Quarantine non-conformance products to avoid contamination and complete necessary reports.

M3 and R5 system.

Triumph Structures, Inc. - Brea, CA

Oct 2014- Aug 2015

Quality Assurance Inspector

Perform quality assurance inspections and complete necessary accompanying reports of outgoing/incoming parts using ISO/AS9100:2004C standards.

QMS Procedures, maintain certificate accreditation for approval & surveys.

Provide audit responses.

First Article Inspection Report (FAIR).

Mechanical/Visual inspection of parts, assemble kits.

Experience in basic tools Micrometers, digital height gages, comparators, pin gage.

QA Documents/Document control, receiving inspections and inventory list.

Used blueprints/diagrams/engineering drawings of components for specific parts to assemble/identified specific parts.

Read and understand drawing criteria, GD&T, notes and tolerances.

Created Reports and Trend Analysis of incoming products to identify non-conformance parts.

Created Corrective Action Reports to present to upper management to communicate the encountered issues to manufacturing companies.

Separate/quarantine non-conformance products to avoid contamination and track product on SAP.

Trained staff as necessary for the company to become well-balanced and to run more efficiently.

Performed data entry on inventory lists.

Used Microsoft (Excel, PowerPoint, Word and Outlook) for reporting.

VIAIR Corporation - Irvine, CA

July 2011 to July 2014

QA Control/RGA Lead Technician

Perform quality assurance inspections and complete necessary accompanying reports.

Use blueprints/diagrams of components or specific parts to identify special orders.

Prepare required paperwork to maintain accurate inventory count and repair compressors.

Assist upper management in passing company audits and maintaining ISO 9001:2008 compliance.

Experience in basic tools Calipers, Tape measure, Radius gages, Protractor, Micrometers, multimeter, torque, comparators, pin gages.

Perform lab testing and welding/soldering electrical parts of the compressors.

Metal Testing Test (Molly test) & Dielectric Strength Test (Hipot test) for incoming products.

Test incoming products for volts, amps & current for special orders or data entry.

Create Reports and Trend Analysis of incoming products to identify non-conformance parts.

Create Corrective Action Reports to present to upper management to communicate the encountered issues to manufacturing companies.

Separate/quarantine non-conformance products to avoid contamination.

Associated Sales International - Santa Ana, CA

October 2009 to February 2011

Supervisor and Sales Assistant

Perform quality assurance inspection of outgoing/incoming parts using ISO/AS9100:2004B standards.

Separated/quarantine dangerous good products for detailed inspections (oils, chemicals, rust, corrosion).

Create reports and Trend Analysis of incoming products to identify non-conformance parts.

Create corrective action reports to present to the owner to communicate the encountered issues to manufacturing companies.

Monitoring parts in a control environment room; ex: temperatures (hot/cold/humidity).

Performed data entry and prepared for inventory counts, audits, and document tracing and tracking.

Place inventory replenishment and re-stocking orders.

Use blueprints/diagrams to identify parts.

Oversaw receipt and shipment of parts using FedEx, UPS, DHL and independent couriers’ systems.

Provided professional and courteous assistance with quotations and requested reports to sales associates.

EDUCATION:

Orange Coast College - Costa Mesa, CA 2022 - Present

Estancia High School – Costa Mesa, CA 1993 - 1997

SKILLS/QUALIFICATIONS:

Computer Literate: Microsoft Office Suite

Auto CAD/Solid Works

CATIA

ERP/ERP/MES: C4C, SAP, JIRA, Splunk, Master Control, SalesForce

DHL, UPS, FedEx Shipping

Windows Visual/Display Presentations

ISO 9001:2008 QA

ISO/AS9100:2004C standards

FDA Medical Device Reporting and Quality System Regulation (21 CFR Part 803, 806, and 820), European Medical Device Directives, and ISO Standards (ISO 13485-QMS, ISO 14971-Risk Management)

Bilingual, Spanish/English

Welding/Soldering

Customer Service

Supervisory Skills

Forklift/Pallet Jack

Calipers & multimeter

Dielectric Test (Hipot)

316 Steel test (Molly)

Current/volts/amps

Power supply machines

Blueprints/diagrams

First Article Inspection Report

Root cause investigation

Mini tab

Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) Protocols

REFERENCES:

Available upon request

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