QC/QA Technician with 15+ years of experience in medical device manufacturing. Expertise in precision inspection, root cause analysis, and quality systems within ISO-regulated environments. Proven ability to reduce defects, improve processes, and ensure compliance through data-driven decision-making and cross-functional collaboration.
Overview
19
19
years of professional experience
Work History
QC/QA Technician
DePuy Synthes – Spine/Orthopedics
Bridgewater
10.2015 - Current
Conduct root cause analysis (RCA) and implement CAPA, reducing defects by 20%
Perform dimensional and functional inspections using CMM, micrometers, and surface testers
Inspect spine, orthopedic (knees, hips), rods, plates, screws, and medical devices to specifications
Evaluate materials and monitor production processes for quality compliance
Author and maintain SOPs and quality documentation for new product lines
Lead cross-functional training on quality standards and inspection procedures
Facilitate internal audits and document non-conformance reports (ISO 9001)
Collaborate with Engineering on system testing, issue identification, and data analysis
Review labeling and documentation to ensure accuracy and regulatory compliance
QC/QA Inspector
Boston Scientific
Quincy
05.2015 - 10.2015
Conducted visual and mechanical inspections on orthopedic products
Ensured compliance with quality and regulatory standards
Conducted thorough inspections of medical devices to ensure compliance with quality standards.
Collaborated with cross-functional teams to identify and resolve product quality issues.
Implemented process improvements that enhanced inspection efficiency and accuracy.
Trained and mentored junior inspectors on best practices in quality assurance protocols.
Analyzed defect trends and provided actionable insights to enhance product reliability.
QC Inspector (Foot Sensors)
Doctor Tech Scan
South Boston
03.2013 - 10.2014
Performed digital pressure testing and verified product accuracy
Utilized precision measurement tools to assess product specifications and identify defects.
Collaborated with production teams to address quality issues and implement corrective actions.
Documented inspection results and maintained accurate records for quality assurance purposes.
Inspector in Quality Assurance and Quality Control
WB Mason
South Boston
09.2012 - 01.2013
Warehouse operations, production support, and equipment operation
Collaborated with production teams to identify and resolve quality issues effectively.
Conducted thorough inspections of materials and products to ensure compliance with quality standards.
Assisted in developing and implementing quality control procedures to enhance product reliability.
Dental Inspector
Atlantis Component & Astra Tech Dental
Waltham
08.2007 - 08.2012
Inspected titanium components using microscopes and precision tools
Verified dimensions and assembled components per specifications
Identified defects and non-conformities in products, facilitating timely corrective actions.
Collaborated with production teams to enhance inspection processes and improve overall product quality.
Conducted thorough inspections of dental components to ensure compliance with quality standards.
Utilized precision measuring tools and equipment to assess component specifications accurately.
Documented inspection findings and generated reports for management review and process improvement initiatives.
Trained new staff on inspection protocols and best practices to maintain consistent quality assurance.
Prepared reports detailing findings of inspections, investigations, and tests.
Education
High School Diploma -
Brighton High School
Brighton, MA
05-1994
Skills
Quality Control
Process Improvement
Lean Manufacturing
ISO 9001 Compliance
Root Cause Analysis (RCA) & CAPA
Six Sigma
Risk Management
Statistical Process Control (SPC)
CMM & Precision Measurement
GD&T
SOP Development
SAP
Microsoft Office
SharePoint
Attention to Detail
Multitasking
Time Management
Communication
Organizational Skills
Problem-Solving
Equipment inspection
Lab equipment maintenance
Auditing
T
Safety protocols
Testing protocols
Trend tracking
Routing inspections
Test execution
Test planning
Regression testing
Quality assurance requirements
Samples comparison
Defect tracking
Materials analysis
Specifications
Corrective action implementation
Data analysis
Quality management systems
Documentation expertise
Test case development
Usability testing
Policy development
Test automation
Production scheduling
Electronic measurement devices
Production line observation
Software testing
Electronic schematics
Inspection reports
Process quality review
Raw materials testing
Quality improvements
Quality assurance
Detail-oriented
Problem-solving skills
Risk management
Verbal and written communication
Materials inspection
Correction action planning
Discretion
Languages
English
Native or Bilingual
Timeline
QC/QA Technician
DePuy Synthes – Spine/Orthopedics
10.2015 - Current
QC/QA Inspector
Boston Scientific
05.2015 - 10.2015
QC Inspector (Foot Sensors)
Doctor Tech Scan
03.2013 - 10.2014
Inspector in Quality Assurance and Quality Control
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