Quality Control Medical Device

Gina Labrador

Senior Quality Control Technician / Medical Device

Tusker Medical/Smith and Nephew - CA Sep 2022 to Mar 2023

• Perform incoming, In-process and Final Inspection of medical device components in adherence to quality procedures, perform line clearance

• QC floor auditor, audit and Review all Device History Records and other quality related documents for

completeness, accuracy, and conformance to SOP, Lot dispositioning

• Write and update inspection procedures and checklists as required.

• Ensures equipment calibration and preventive maintenance are up-to-date

• Generate Non-Conforming Material Reports (Client) and Initiate Material Review Board (MRB) For NonConforming Materials, initiate deviation

• Perform First Article Inspections audit and dimensional measurements

• Perform final product release and testing of finished goods.

• QC Packaging inspection such as labeling, pouching sealing and box inspection for In-Process and Final

process

• Assist in returned product failure investigation

• Collaborate and coordinate with R&D, Engineering Dept. regarding protocols and other related quality

issues

• Supplier Monitoring

Perform Senior analysis

Quality Control Master Associate

Boehringer Ingelheim - Fremont, CA

May 2018 to April 2022

• Performs sampling/inspection of raw materials (chemicals and packaging materials) and medical

device components based on engineering drawings using measuring tools and equipment like calipers,

micrometers, pin gauges, block gauges calibrated rulers) and other measuring machines, AQL inspection

(e.g., visual defects, dimension testing, and all required attributes

• Creates inspection forms, revises material specifications, SOPs, initiates deviations and non conformity

reports

• Lead person, trainer and QC contact person for Raw Material Incoming Inspection for Medical devices

and Packaging Components

• Prepares inspection documentation and verification of supplier's documentation such as COA, COC,

sterility paperwork and other process forms required for incoming inspection

• Prepares documentation for samples for shipment to appropriate testing laboratories

• Audit and review material inspection forms, chemical sampling forms after completion

• Creation of LIMS ID and other performs LIMS transaction on material and chemical sampling

• Prepares Material summary form for product release, Reviews batch record prior to disposition

• Performs logbook and/or LIMS entries when using equipment/instruments. Reconciles samples

• Ensures equipment calibration and preventive maintenance are up-to-date

• Maintain laboratory cleanliness and orderliness

• Knowledge of LIMS, SAP and R & R Gage

Quality Control Technician /Batch Record Reviewer, Medical Device

Manufacturing

Tusker Medical - Menlo Park, CA

October 2017 to May 2018

• Perform incoming, In-process and Final Inspection of medical device components in adherence to quality

procedures, perform line clearance

• QC floor auditor, audit and Review all Device History Records and other quality related documents for

completeness, accuracy, and conformance to SOP, Lot dispositioning

• Write and update inspection procedures and checklists as required.

• Ensures equipment calibration and preventive maintenance are up-to-date

• Generate Non-Conforming Material Reports (Client) and Initiate Material Review Board (MRB) For NonConforming Materials, initiate deviation

• Perform First Article Inspections audit and dimensional measurements

• Perform final product release and testing of finished goods.

• QC Packaging inspection such as labeling, pouching sealing and box inspection for In-Process and Final

process

• Assist in returned product failure investigation

• Collaborate and coordinate with R&D, Engineering Dept. regarding protocols and other related quality

issues

• Supplier Monitoring

SR Quality Control Inspector, MFG Floor auditor

IMPAX Laboratories (company shutdown) - Hayward, CA

August 2016 to October 2017

• Performs quality assurance processes according to written procedures; document inspection results

• Recognizes routine deviations from procedures and resolves problems.

• Train junior QA Technicians in the performance of their cGMP duties.

• Performs in-process audit(i.e., hardness, diameter, thickness, etc.) and AQL Attribute inspection.

• Perform line clearance and release of materials

• Perform real-time batch record reviews.

• Perform Commercial Manufacturing Area clearance of processing rooms, equipment and materials.

• Tag equipment for swabbing, out of service and release

• Verifies data entries on quality records.

• Assist in investigate of production and procedural errors.

• Responsible for managing the details of their assigned tasks to ensure accurate and timely

documentation of manufacturing and inspection activities.

• Trains new employees on Quality Assurance procedures.

• Perform Good Manufacturing Practice (cGMP) audits of manufacturing and warehouse areas.

• Revises departmental procedures (SOPs) as necessary to ensure compliance to regulatory standards

and company policy.

• Collaborates with Manufacturing, Technical Services, and Engineering to solve production line issues

and problems

Sr Quality Control Inspector, Production

Eargo - Mountain View, CA

November 2015 to June 2016

• Perform in-process and final inspection of components and finished goods

• Prepare documentation for inspection; verification of labels; line clearance

• Tagging of discrepant materials; participate in the initiation of nonconforming assembly and

components

• Post process final inspection of labels and packaging

• Review documentation for accuracy before shipment;

• Review and audit DHRs, filing and archival of quality records and other document control functions

• Coordinate with Production Dept. regarding production scheduling

• Data entry of patient info and other pertinent details in the database

SR QA Inspector, Medical Device Manufacturing

Abbott Vascular - Menlo Park, CA

September 2014 to November 2015

• Perform incoming raw materials, in process of components and final inspection of finished goods

• Perform final mechanical and visual inspections under the microscope for final assembly; tagging,

verification of labels; releasing

• Perform leak test and other QA testing, final label inspection, documentation of all tests and

measurements.

• Identification of nonconformance assembly, support investigation

• Prep and audit QA documentation for all IQA inspectors prior to inspection.

• Inspect incoming materials using visual inspection standards using measuring tools such as caliper,

gauges, micrometer, etc based on Engineering drawings and specifications

• Perform AQL sampling and quality testing of raw materials

• Generate QA documentation for QA inspectors based on QIPs, Engineering

• drawing and specifications; maintaining all QA documentation

• Audit and review all incoming documentations such as COC, COA, labeling, packaging

• in conformance with quality standards prior to inspection; updating status of materials

• Computer transaction of all raw materials prepared for QA inspectors

• Coordinate with SQE regarding NCMRs and MRB and other quality issues

• Perform electronic transaction of Lot History (paperless), Line clearance

SR QC Technician- Medical Device Manufacturing

TriReme Medical - Pleasanton, CA

December 2013 to September 2014

• Inspect incoming materials like tubing and machine parts using visual inspection standards under the

microscope by using measuring tools such as caliper, gauges, micrometer for medical device

• AQL sampling and other quality testing of raw materials,100% inspection and testing of finished

products

• Report product issues to QA Manager, Process Engineering and manufacturing for resolution;

coordination with Production Scheduler

• Interpretation and understanding of engineering drawings; generating files for inspection and other

pertinent documents

• Verify, audit & review batch record for product release for packaging

• Line clearance/sign off of manufacturing process lines; releasing of parts and sub assembly

• Post process final inspection of catheters such as pouching, seal and labeling inspection; submission

of QA documentation and photos for nonconformance materials

• Interface with engineers with new product development; inspect, perform testing snd support other

activities for R & D

• Maintain quality control inspection documentation and actively participate in updating and revising

SOPs, QCIs and other forms.

• Work in a cleanroom, cGMP and FDA regulated facility

Pharmaceutical Asso. II

Zosano Pharma (clinical trial discontinued) - Fremont, CA

April 2013 to December 2013

• Support clinical manufacturing activities in running the process for the Manufacturing & Pilot plants for

pharmaceutical medical device product; aseptic technique

• Inspection and receiving of materials; preparation and submission of samples for QC lab

• Equipment set-up operation, troubleshooting, and dismantling.

• Assist Engineering in support of process development activities; chemical handling

• Visual inspection using the microscope and other testing; room preparation for line

• Complete and review production records to ensure cGMP documentation is in compliance

Incoming QC Inspector, Medical Device

In-Sound Medical Systems - Fremont, CA

February 2013 to April 2013

• Perform visual inspection of medical device under the microscope and ensure that they are consistent

with the specifications used measuring devices such as calipers, micrometers, gauges, etc.

• Inspection and receiving of materials and perform lot reconciliation

• Report any unusual defects and results for further analysis; documentation

• Audit, review documentation for product release

SR QC Inspector

Neophotonics - San Jose, CA

June 2012 to February 2013

• Perform visual microscope inspection/dimensional inspection of electronic, machine parts, materials,

and assemblies and ensure they are consistent with specifications and procedures; product release

inspection

• Interpret and understanding of Engineering drawings, C of C, inspection sheets and other pertinent

documentations attached

• Perform First Article inspections to qualify tooling and new parts as applicable; maintains the accuracy

of identification and count of materials.

• Generate Non-conforming Material Reports(NCMR's) for materials that do not meet specifications

• Proficient using calibrated hand measuring tools like calipers, micrometers, gauges

• Track materials through the inspection process and maintain Receiving Inspection records; perform

Oracle transaction

QC Inspector, Medical Device

Johnson & Johnson - Fremont, CA

August 2010 to May 2011

• Visual inspection of stents and catheters under the microscope

• Worked with measurement devices such as calipers, gauges, pins, micrometers and performed

dimensional measurement; receiving & labeling

• performed QA testing in accordance to Engineering protocols

• Quality control functions in support for R&D; issuance of QA documentation for the lab; audit and review

of batch record

• Inspect receive parts label, package; lot reconciliation

• Inspect and verify the product and documentation to release final product for shipment.

• Collected data and generate reports for shift pass down

Impax Laboratories, Hayward, CA

Pharmaceutical Technician

Pharmaceutical Tech - Hayward, CA

November 2009 to August 2010

• Setting up/assembly and operation of machines, preparing active pharmaceutical ingredients and

aqueous solutions; running the process such as mixing solution, blending & granulation to make pills,

tablets and capsule oral drugs; cleaning of the machine parts, vessels and tanks & room;

• Setup for the next run/changeover procedure; documentation & lot reconciliation;

• Receiving & inspection of materials; chemical handling of raw materials; labeling & packaging

• Cleanroom, GMP, FDA regulated, aseptic technique

Pharmaceutical Technician

Johnson & Johnson - Vacaville, CA

April 2002 to June 2009

• Perform commercial manufacturing activities (form, fill, and seal) for transdermal cancer products;

inspection of materials & parts; set up/assembly, operation & troubleshooting of machines, packaging

of pouches;

• Visual inspection & in process testing; labeling; documentation; audit & end of lot reconciliation of

batch records; chemical handling; corrective action procedure

• Performed computer production transactions; daily shift pass down; cleaning of vessels, tanks and sub

assembly parts; changeover procedure; functions are performed in compliance with SOP, GMP, OSHA

DEA & FDA regulations

• Worked hands on with the inspection of products using measurement tools

• Cleanroom, GMP, DEA and FDA regulated, aseptic technique

Education

Bachelor of Science in Management/Marketing

St Paul University

Bachelor's

Solano College of Nursing

Skills

• Micrometer

• Calipers

• CGMP

• Dimensional Inspection

• Quality Inspection

• Process Engineering

• Research & Development

• Manufacturing

• Calibration

• Aseptic Technique

• Laboratory Experience

• Product Development

• Document Management

• Production Planning

• FDA Regulations

• GD&T

• Microscopy

• Visio

• Lean Manufacturing

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