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Ashley Gurak
San Jose
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
9
9
years of professional experience
Work History
Quality Engineer III
Intuitive
03.2023 - Current
- Author of Master Validation Plan and Reports (MVP & MVR)
- Owner of Risk Management Plan and Report (RMP & RMR)
- Review and provide thorough feedback on Engineering Change Orders (ECOs), ensuring compliance to QMS and regulatory requirements
- Review & approve SAP Quality Notification workflows (NC, VR, EE, DN, SCR & RR)
- Lead Escalations and Product Recalls for identified product issues with field impact or high severity (Insertion Screw, Harmonic Drive Plug)
- Certified Lean Six Sigma Project Owner: FIM Cover Cosmetic Acceptance, Escalation Process Improvement
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Guided transition to quality management system updates (QIP), minimizing disruption and aligning with best practices.
Quality Systems Engineer
Atalys (EG Industries)
09.2022 - 03.2023
- System Improvement Lead for Calibration of Gages and Devices (QMS Development Project)
- Managed CAPA System and enforced completion of all applicable activities per customer notifications (Link Sulu Material Discrepancy)
- Coordinated with ISO 13485:2016 during audits, ensuring continued certification and compliance to standard. (Front Room Audit Support for DNV Certification and Surveillance efforts)
- Assisted with development of controlled quality documentation tools (Control Plan, PFMEA, Process Flow)
Quality Engineer
Röchling Medical Rochester
04.2017 - 09.2022
- Quality Engineer for new product development, Strong foundations in IQ/OQ/PQ validation reporting, dimensional analysis, and injection molding process review
- Utilized mechanical engineering background to assist with development of complex product assembly lines (Pediatric Curette 16 Cavity Tool Packaging Automation)
- Implemented ISO 13485:2016 PFMEA Template to standard work
- Drafted and executed in-process instructions and receiving inspection instructions, experience with CMM and OGP Inspections
- Certified internal auditor, familiarized with FDA 21 CFR 820, and participant for all external audits (ISO 13485) to maintain site certifications
- Managed customer returns and performed thorough investigations of all returns to verify legitimacy (Single Use, Blood Collection Kit - Missing Spray)
Quality Engineer
EG Industries
08.2015 - 04.2017
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department (IQ / OQ/ PQ Phase Gate FAI Review).
- Management Review Meeting Contributor: Analyzed metrics and developed dashboard to monitor quality trends, enabling data-driven decision-making.
- Spearheaded Clean Room environmental testing for products, ensuring resilience under various conditions (DicksonOne Monitoring Project)
Education
Master of Science - Manufacturing Leadership
Rochester Institute of Technology
Rochester, NY12.2024
Bachelor of Science - Mechanical Engineering
University At Buffalo
Buffalo, NY05.2015
Skills
- FDA GMP
- 21 CFR 820
- ISO 13485
- CAPA
- 8D
- SCAR
- Green Belt Certified
- IQ / OQ / PQ
- PPAP
- APQP
- Injection Molding
- MIM
- Hardware Assembly
- IATF 16949:2016
- Internal Auditor
- Agile
- IQMS
- INFOR
- SAP
- Snowflake
- Minitab
- SPC
- QC Calc
- KPI
- GD&T
- Confluence
- Microsoft Office
- Visio
- Teams
- Lucidchart
- SmartDraw
- Solidworks
- Autodesk
Websites
Interests
Timeline
Quality Engineer III
Intuitive
03.2023 - Current
Quality Systems Engineer
Atalys (EG Industries)
09.2022 - 03.2023
Quality Engineer
Röchling Medical Rochester
04.2017 - 09.2022
Quality Engineer
EG Industries
08.2015 - 04.2017
Master of Science - Manufacturing Leadership
Rochester Institute of Technology
Bachelor of Science - Mechanical Engineering
University At Buffalo
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