Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

ANDREW ALBRIGHT

Camillus

Summary

Quality Engineer with over 8 years of combined experience in medical device manufacturing, pharmaceutical testing, and beverage quality control. Experienced in PFMEA development, statistical process control, root cause investigations, and regulatory compliance (FDA, ISO 13485). Known for supporting cross-functional teams, driving issue resolution, and contributing to process improvements that enhance product quality and consistency.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Quality Engineer

Tessy Plastics
Elbridge
02.2023 - Current
  • Maintain PFMEA, Control Plan, and Process Flow documentation for high-volume medical device manufacturing programs.
  • Lead IQ/OQ/PQ validations for molded and assembled components, developing inspection strategies and ensuring traceability.
  • Conduct root cause investigations using dimensional analysis, force testing, CT scans, and visual inspection methods.
  • Support customer-facing quality responses, including CAPA closures and complaint investigations, with traceability and risk documentation.
  • Coordinate cross-functional efforts to resolve issues such as weld defects, dimensional instability, and flow imbalances.
  • Develop and apply statistically sound sampling plans per ANSI Z1.4 for in-process and rework verification.
  • Track material lots and tooling events to identify trends and systemic issues impacting product quality.
  • Perform internal quality audits and drive continuous improvement initiatives to reduce variation and improve process capability.
  • Manage customer-directed deviations and requalification activities, documenting containment and corrective actions.

Quality Assurance Analyst

Anheuser-Busch InBev
Baldwinsville
04.2017 - 03.2019
  • Conducted quality audits across brewing and packaging operations to prevent release of non-conforming products.
  • Performed chemical and physical analyses on raw materials and finished goods.
  • Managed disposition of non-conforming products using structured root cause analysis.
  • Collaborated with vendors and logistics to address off-spec deliveries and qualify new materials.
  • Supported lab instrumentation upkeep and internal cost-saving initiatives.
  • Enforced SOP compliance through Operational Work Diagnostics and development of One Point Lessons.
  • Participated in Plant Optimization initiatives and Lean Six Sigma improvements.

Scientist I

ICON plc
Whitesboro
03.2016 - 03.2017
  • Executed and validated biological immunoassays in preclinical and clinical biologics development.
  • Maintained data integrity and documentation in compliance with FDA guidelines.
  • Supported study execution and timely delivery of client-ready data.

Education

B.S. - Biological Sciences

University at Buffalo
Buffalo, NY
01.2016

A.S. - Biology

Mohawk Valley Community College
Utica, NY
01.2014

Skills

  • PFMEA
  • Process Control
  • SOP Auditing
  • Validation & Qualification (IQ/OQ/PQ)
  • Root Cause Analysis (5-Why, Fishbone)
  • Statistical Tools (Cp, Cpk, SIM, DOE)
  • Sampling Plans (ANSI/ASQ Z14-2003 (R2018), MIL-STD-105E)
  • Cleanroom Manufacturing & Inspection
  • Customer Complaint Response & CAPA
  • Quality Audits & Continuous Improvement
  • Lean / Six Sigma Methodologies
  • Regulatory Compliance (FDA, ISO 13485)

Certification

  • ISO 13485 & 14971 Risk Management Fundamentals
  • CAPA Investigator & Deviation Analyst
  • Minitab & Statistical Process Control

Timeline

Quality Engineer

Tessy Plastics
02.2023 - Current

Quality Assurance Analyst

Anheuser-Busch InBev
04.2017 - 03.2019

Scientist I

ICON plc
03.2016 - 03.2017

B.S. - Biological Sciences

University at Buffalo

A.S. - Biology

Mohawk Valley Community College

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