WORK EXPERIENCE

Oxenham Group| 2021 - Present
Quality Engineer, Stryker Orthopedics

PFMEA remediation to ensure compliance with EU MDR
Review and approve updated production process flows
Interface with RA to appropriately respond to notified and regulatory bodies
Support the harmonization of legacy products with the Stryker quality system
PFMEA remediation to Stryker standards as well as to ensure compliance with EU MDR and domestic guidance

Medical Device Manufacturer | 2018-2021
Quality Engineer II

Lead Quality Engineer for launching 5 new product lines including Two Finished Medical Devices
Launching Duties include:
- Implement proper controls/documentation to meet FDA Title 21 CFR Part 820
- Device History Records (DHR) and Device Master Record (DMR)
- Advance Quality Planning (AQP) & Validation Planning
- IQ/OQ/PQ and PPAP
Other Duties include:
- CAPA, SCIR, SCAR
- PFMEA & Control Planning
- ISO 14001, ISO 13485, ISO 9001, IPC-A-610
- Containment, Bounding, Data Analysis, Root Cause Analysis, Risk Analysis
- Customer/Supplier Communication & Audit Participation

Medical Device Manufacturer | 2018
Quality Engineer, Complaint Investigator

Root Cause Analysis - Document Review, Quality Control, Validation, Device History Records
Device Failure Analysis - Drawings, Specifications, Instructions for Use, Non-conformances
Prepare Response Letters for Worldwide Health and Safety Agencies
Risk Assessment - CAPA, FMEA, Risk Potential and Severity, Occurrence Rates, Sale

EDUCATION
Lawrence Technological University, Southfield, MI
Masters of Science in Biomedical Engineering | 2016-2018

Central Michigan University, Mt. Pleasant, MI
Bachelors of Science in Secondary Education, Double Major: Math/Physics | 2007-2013

CERTIFICATIONS
Lean Six Sigma - Bronze | 2020
Defect/Rework Project resulted in an Annual Hard Savings of $120,000

TEACHING EXPERIENCE
Romulus Muskegon Schools | 2013-2016
Middle/High School Teacher: Math/Physics