Nuvasive Orthopedics - Quality Inspector, March 2019 - Sept 2014
Endologix, INC. - Quality Inspector, 2005 - 2017
Education and Training
Timeline
Mubira Horiuchi
Mission Viejo,CA
Summary
Hardworking quality control inspector offering several years of manufacturing and production experience. Detail-oriented and systematic professional knowledgeable about Receiving/cleanroom inspection compliance standards. Adheres strictly to documentation guidelines and industry regulations. Strong understanding
of ISO 13485, GDP, GD&T, and GMP standards.
Overview
23
23
years of professional experience
Work History
Quality Control Inspector
SEE EMPLOYER HISTORY LIST
03.2002 - 09.2024
Performed first article inspection on incoming raw materials.
Maintained records of all nonconforming products and completed corrective actions as required.
Adhered to safety protocols to minimize equipment damage and avoid injuries.
Matched arriving components with purchase orders, lot numbers, certs, material certs, and data inspection discrepancy forms as necessary.
Used root cause analysis tools to determine failures and provide appropriate countermeasures to prevent repeat failures.
Inspected repaired products to meet project expectations.
Trained new employees on proper use of test equipment and inspection techniques.
Used compatible measurement tools to take precise measurements of various aspects of samples.
Adhered strictly to Good Manufacturing Practices guidelines at all times.
Completed non-destructive tests and conducted continuous inspections.
Assessed materials, parts and products for conformance with quality control requirements and production specifications.
Ensured that all products met customer requirements prior to shipment.
Assisted engineering department with design verification tests as needed.
Produced official reports of findings to meet regulatory standards and assist senior leadership with improving operations.
Identified production concerns and worked with supervisors to understand and remedy situations.
Tested finished goods prior to shipment according to established protocols.
Documented inspection results by completing reports and logs and summarizing and entering data into quality database.
Notified supervisors or other relevant personnel of test or production issues.
Noted changes during testing in project documentation.
Compared product and materials colors, shapes, textures and grades with predetermined templates.
Oversaw proper tagging and identification of parts and components, enabling rejected or non-repairable parts to be properly marked, quarantined and rendered unusable.
Wrote detailed reports outlining performance, quality and defect rates.
Recommended improvement measures to production process to meet quality control standards.
Cleaned and calibrated dial indicators, fixed gauges, or height gauges prior to tests.
Selected samples for use as test models.
Recommended essential corrective actions based on test results.
Marked materials with grade or acceptance status.
Collaborated with cross-functional teams to resolve complex problems related to product design or manufacturing processes.
Positioned components, parts or materials for testing.
Analyzed data from process control systems to identify trends in product quality.
Documented nonconformities and recommended techniques for prompt resolution.
Administered competency tests to determine engineers or operators are qualified to use equipment.
Participated in internal and external audits to ensure compliance with applicable regulations.
Inspected products for defects and conformance to customer specifications using precision measuring instruments.
Read blueprints and manuals to determine test procedures or adjustment methods.
Verified accuracy of product labels, including expiration dates and lot numbers.
Identified areas for improvement in existing processes, procedures, and equipment.
Trained newly hired employees by explaining company procedures, job duties and performance expectations.
Generated reports summarizing inspection results, defect trends, and other statistical data.
Analyzed plans, specifications and blueprints to understand product requirements.
Inspected, tested and measured materials for conformance to specifications and regulatory requirements.
Monitored production processes to ensure quality standards were met and documented results of inspections.
Achieved cost-savings by developing functional solutions to problems.
Contributed innovative ideas and solutions to enhance team performance and outcomes.
Operated a variety of machinery and tools safely and efficiently.
Provided support and guidance to colleagues to maintain a collaborative work environment.
Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
Collaborated closely with team members to achieve project objectives and meet deadlines.
Prioritized and organized tasks to efficiently accomplish service goals.
Utilized advanced technical skills and expertise to troubleshoot complex problems and implement solutions.
Utilized smart scope software and fixtures to optimize performance and reduce inspection time.
Education
High School Diploma -
Costa Mesa High School
Skills
Digital caliper
Micrometer
Optical smart scope
Microscope
comparator
Pin gauge
Height gauge
Block gauge
Angle gauge
Protractor gauge
Ruler
Depth gauge
Snap/Thickness Gauge
Torque wrench
Thread gauge
First article inspection
CMM
Product Work Order
Receiving component inspection paperwork process
QAD system/ Pre-Printed NCR form
Nuvasive Orthopedics - Quality Inspector, March 2019 - Sept 2014
Receiving component Quality Inspector
Clean room Quality Inspector
1st Article, In-house tooling qualification inspector, R&D parts inspector
Returned/Reworked/ Sterile lot inspector
Finished Good Inspector
Endologix, INC. - Quality Inspector, 2005 - 2017
Receiving Component Quality Inspector
Clean room Quality Inspector
1st Article, In-house tooling qualification inspector, R&D part inspector
Currently working - farmers market at Employer History Is Beyond 10+ Years AgoCurrently working - farmers market at Employer History Is Beyond 10+ Years Ago