Summary
Overview
Work History
Education
Skills
Accomplishments
BD Silver CAPA Award
Timeline
Generic

JOSHUA BILECKY

Scarborough,ME

Summary

Quality engineering professional with strong background in ensuring product and process excellence. Skilled in root cause analysis, process optimization, and compliance with industry standards. Proven ability to collaborate effectively with teams, adapt to changing needs, and deliver impactful results. Known for reliability, problem-solving skills, and commitment to quality.

Overview

8
8
years of professional experience

Work History

Quality Engineer

ABBOTT
06.2023 - Current
  • Installed Lean Manufacturing methodologies, Continuous Improvement efforts, and Audit prep programs into a site that did not have a line quality engineering team
  • Teach monthly seminars to production staff on subject matter from ISO 9001 and 21 CFR Part 820 as a part of a "Quality Topic of the Month" initiative

Quality Engineer/Quality Specialist

ABBOTT
10.2022 - 03.2023
  • Assisted an Abbott Nutrition site in Sturgis, Mi that had entered under a Consent Decree with the FDA to review a backlog of Food Safety and Sanitation procedure nonconformances
  • Participated in backroom activities in a for-cause FDA Audit
  • Served as SME for FDA 483 finding following nonconformance backlog review, supporting site response to the observation and providing support and guidance on corrective and preventative actions

Manufacturing Line Quality Engineer

ABBOTT
02.2022 - 10.2023
  • Participated in and led many activities in transitioning inventory systems across 2 major manufacturing sites from FourthShift to SAP and operated as an SME after installation
  • Identify and document nonconformances, provide justifications to assist with material disposition, and write reprocessing records
  • Led team to map and design material process flow for 2 manufacturing sites to aide in lean manufacturing efforts

Lab Tech I - Quality Engineer II

BECTON DICKINSON (previously C.R. BARD)
12.2017 - 01.2022
  • Managed a team of 5 Quality Engineers that were responsible for completing over 250 Complaint Sample Investigations per month across multiple manufacturing sites
  • Developed FDA product failure code workshops, job aids, and lab best practices for new hire training that was taught to over 50 new hires
  • Completed many CAPAs with one project receiving the Global Silver CAPA Award for BD

Education

Bachelors of Science - Biology with Concentration in Biotechnology

Kennesaw State University
Kennesaw, GA
07.2017

Skills

  • Non-conforming material reports
  • Quality processes
  • Root-cause analysis
  • Lean manufacturing tools
  • Team leadership
  • Corrective and preventive actions
  • Quality documentation
  • Process mapping
  • Continuous improvement
  • Customer complaint handling

Accomplishments

  • Reduced nonconformance occurrences by 42% in manufacturing operations through strategic implementation of poka-yoke error-proofing techniques across key process areas

BD Silver CAPA Award

Led a team of five Quality Engineers to resolve transcription errors identified in complaint test method data. Conducted a large-scale review of thousands of data points across hundreds of investigations, corrected integrity issues, and implemented preventative measures within the approval process to ensure early detection of future errors. These efforts strengthened data reliability and earned Silver CAPA recognition, a global BD award.

Timeline

Quality Engineer

ABBOTT
06.2023 - Current

Quality Engineer/Quality Specialist

ABBOTT
10.2022 - 03.2023

Manufacturing Line Quality Engineer

ABBOTT
02.2022 - 10.2023

Lab Tech I - Quality Engineer II

BECTON DICKINSON (previously C.R. BARD)
12.2017 - 01.2022

Bachelors of Science - Biology with Concentration in Biotechnology

Kennesaw State University

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