Summary
Overview
Work History
Education
Skills
Websites
Certification
Patent
Timeline
Generic

Cassandra Van Allen

Springdale

Summary

Senior Manager in Quality Engineering with extensive experience at Becton Dickinson, achieving a 62% reduction in nonconformances. Proficient in global medical device regulations and quality management systems for medical device manufacturers (ISO 13485), demonstrating strong leadership in mentoring teams, and driving compliance initiatives. Focused on delivering high-quality medical devices through effective collaboration across functions.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Senior Manager, Quality Engineering

Becton Dickinson
Tempe
08.2023 - Current
  • Directed site quality operations at Tempe manufacturing, managing a team of up to 21 staff members.
  • Represented the quality function during audits, achieving zero major nonconformances with multiple regulatory agencies, including BSI, FDA, Taiwan FDA, etc.
  • Achieved a 62% reduction in nonconformances within one year through systematic improvements.
  • Developed key performance indicators for monitoring plant performance metrics effectively.
  • Ensured compliance with industry regulations and internal policies throughout operations.
  • Provided quality engineering support for product verification, reliability testing, and validations.
  • Implemented comprehensive updates to the Quality Management System and various initiatives.
  • Led cross-functional investigations into ongoing product and system issues.

Manager, Quality Engineering

Becton Dickinson
Tempe
01.2019 - 07.2023
  • Manage a team of up to 10 Quality Engineers supporting medical devices pre and post commercialization.
  • Recruit and develop Quality Engineering professionals to support pre and post commercialization medical devices.
  • Serve as subject matter expert for cross-functional product development teams on various Quality items including Risk Management, Design Controls, and statistical techniques.
  • Ensure appropriate resourcing to cross-functional product development teams.
  • Collaborate with R&D organization and manufacturing sites to ensure Quality deliverable are fulfilled on product development teams and robust medical devices are commercialized.
  • Train and mentor Quality Engineers to work within international regulations for medical devices as well as company policies and procedures.
  • Lead and collaborate Risk Management improvements to comply with international regulations throughout the product lifecycle.
  • Lead and mentor Quality Engineers through product and Quality System investigations, test method validations, design verification and process capability studies, equipment qualifications, process validations, sterilization validations, biocompatibility evaluations, shelf-life determination studies as well as evaluation of data for statistical validity.
  • Lead Quality System integration and DHF/DMR transfer with product acquisitions.

Quality Engineer II & Senior Quality Engineer

Bard Peripheral Vascular
Tempe
11.2013 - 12.2018
  • Provide QE representation on PMA, 510(k), Stent Graft, Surgical, and Stent product teams.
  • Lead projects like developing electronic IFU and master risk UFMEA/DFMEA.
  • Develop physical and functional test methods, process validations (IQ, OQ, PQ), and ensure statistical validity.
  • Manage Quality Engineers.
  • Provide technical direction during design transfer activities.
  • Perform process improvement, control, and monitoring on manufacturing processes.
  • Lead quality issue investigations, determine root causes, and initiate remedial actions.
  • Monitor supplier quality issues and initiate corrective actions.
  • Develop and implement procedures and training to ensure compliance with corporate and industry standards.
  • Provide support to the Regulatory department in writing technical submissions.
  • Initiate new and revised documentation through the internal change control process.
  • Prepare and present project updates and technical discussions.

Field Assurance Engineer I & II

Bard Peripheral Vascular
Tempe
08.2010 - 11.2013
  • Led complaint and service and repair investigations and analyzed trends.
  • Supervised Field Assurance Coordinator and led various training sessions.
  • Formulated responses for regulatory inquiries and executed post market reviews.
  • Evaluated and investigated biohazard complaint samples.
  • Provided training on product and complaint investigations.

Education

Master of Science - Quality Assurance, Manufacturing

California State University, Dominguez Hills
08.2020

Bachelor of Science - Bioengineering

Arizona State University
05.2010

Skills

  • Microsoft Office Suite
  • Minitab software
  • Six Sigma Green Belt
  • FDA regulations compliance
  • Quality Management Systems for Medical Device Manufacturers - ISO 13485
  • cGMP practices
  • Medical device regulations
  • Good distribution practices
  • ASTM standards knowledge
  • AAMI guidelines familiarity
  • ISO standards expertise
  • DMAIC methodology
  • Root cause analysis
  • Leadership capabilities
  • Management experience
  • PPAP
  • FMEAs
  • Gage R&R
  • Calibration systems
  • CAPA
  • Audit preparation
  • Supplier quality
  • GD&T familiarity

Certification

Six Sigma Green Belt

Patent

Endovascular Cutting Catheter and Related Method, US11471184, 10/22

Timeline

Senior Manager, Quality Engineering

Becton Dickinson
08.2023 - Current

Manager, Quality Engineering

Becton Dickinson
01.2019 - 07.2023

Quality Engineer II & Senior Quality Engineer

Bard Peripheral Vascular
11.2013 - 12.2018

Field Assurance Engineer I & II

Bard Peripheral Vascular
08.2010 - 11.2013

Master of Science - Quality Assurance, Manufacturing

California State University, Dominguez Hills

Bachelor of Science - Bioengineering

Arizona State University

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Cassandra Van Allen