Andrew Palko
Director of Quality, Operations
- Role
- Director of Quality, Operations at Philips
- Location
- Pittsburgh, PA, US
- LinkedIn followers
- 500 followers
About Andrew Palko
Currently, I am working with Philips Respironics as a Quality Manager, Operations. I served as Manger of Quality Systems/Post Market Surveillance and Manufacturing Quality Engineer with the Vent Business Unit prior to this role.Previously, I worked for nearly 5 years with Best NOMOS, a medical device manufacturer as Quality Engineer and Manager of Quality and Regulatory Affairs. In that position, I served as management representative for external audits, both ISO and FDA. I strive to continue my career in the medical device industry, growing more technically competent while remaining dedicated to quality.Specialties: ASQ Certified Quality EngineerISO 13485 and 14971, FDA QSR 820, European Medical Device Directive, and Canadian Medical Device Regulation
Experience
Director of Quality, Operations
Mar 2023 — Present · Pittsburgh, PA, US
Education
Robert Morris University
BS, Manufacturing Engineering
2000 — 2004
Robert Morris University
MS, Engineering Management
2004 — 2005
Skills
- Manufacturing
- Quality Assurance
- Quality Management
- Engineering
- Iso 13485
- Software Documentation
- Quality Auditing
- Lean Manufacturing
- Root Cause Analysis
- Cqe
- Design Control
- Iso
- Fda
- Management
- Continuous Improvement
- Medical Devices
- Capa
- Quality Control
- Problem Solving
- Product Development
- Quality System
- Quality Systems
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