Felix Le is a highly qualified professional, working in Wilson Wolf Manufacturing Corporation on the position of Director of Qa and Ra since 2020. This expert gained professional experience in more than 12 positions at various companies. Felix Le went to the University of Minnesota - Carlson School of Management and got education from 1989 to 1989. This person has the following qualifications: License 43405, License 31248, and License 5312. Saint Paul, Minnesota is the city, where this professional was lastly known to settle. Their phone number and email can be accessed through SoftwareOfficial on demand.
Name variants:
Lix Le
Last updated May 14, 2024
Contact Information
Last Update
Jul 11, 2022
Email
pl**@me.com
Location
Saint Paul, MN
Company
Wilson Wolf Manufacturing Corporation
Workplace
Director of Qa and Ra
Work History
Medical Device Quality Consultant - Supplier Qa To Contract Mfg
Provide manufacturing quality support to contract manufacturer
from Apr 2019
Medical Device Quality Consultant - Project Management
6000 Shoreline Ct SUITE 101, South San Francisco, CA 94080
Facilitate and track process improvement and closure of remediation/compliance activities
Jan 2018 — Feb 2019
Medical Device Quality Consultant - Capa Lead and Specialist
500 Old Connecticut Path, Framingham, MA 01701
HeartWare is a global Class III medical device company dedicated to creating revolutionary technology for the treatment of heart failure, which enable patients to get back to life.
Apr 2015 — Apr 2018
Medical Device Quality Consultant - Nonconformance
4555 Riverside Dr, Palm Beach Gardens, FL 33410
Conduct, review, and approve Non-conformance Reports.
May 2014 — Feb 2015
Medical Device Quality Consultant - Management Reviews
275 north Field Dr, Lake Forest, IL 60045
Management Review process, metrics, and related documentation
Aug 2013 — Dec 2013
Medical Device Quality Consultant - Supplier Quality and Non-Produce Software Validation
265 Davidson Ave, Somerset, NJ 08873
Supplier quality management/engineering consultation and support.
Software validation
PFMEA Activities
Jan 2011 — Aug 2013
Medical Device Quality Consultant - Nonconformance and Qa Management
Minnesota
Manufacturing Quality Engineering Management
2010 — Feb 2011
Director, Qa and Ra
Responsible for maintaining ATEK's compliance with FDA regulations as well as international regulatory policies and overseeing the company's continuous quality improvement processes.
Jul 2008 — Sep 2010
Senior Quality Engineering Manager
710 Medtronic Pkwy, Minneapolis, MN 55432
Held positions of increasing responsibility in providing quality engineering support for R&D and Operations including manufacturing & supply chain, and pharmaceutical.
1991 — 2008
Senior Electrical Engineer
2929 Walnut St, Philadelphia, PA 19104
Held positions in microprocessor-based engineering, software development, software quality assurance, quality assurance and improvements.
1984 — 1991
Education
1984 — 1984
Occupations
Executive
Director
Counselor
Sales Specialist
Supplier
Operations Manager
Advisor
Services Professional
Sales Representative
Skills
Quality System
Iso 13485
Fda
Medical Devices
Quality Assurance
Capa
Validation
Design Control
Manufacturing
V&V
Quality Control
Iso 14971
Continuous Improvement
Six Sigma
Fmea
Design of Experiments
Root Cause Analysis
Change Control
Supplier Quality
Quality Auditing
Quality Management
Biomedical Engineering
Process Simulation
Regulatory Affairs
Lean Manufacturing
Gmp
Dmaic
Iso
Spc
Process Improvement
Ce Marking
Software Quality Assurance
Design Assurance
Testing
Minitab
Software Documentation
Quality Systems
Manufacturing Quality
21 Cfr
Computer System Validation
Software Validation
Medical Tourism
Process Validation
Contract Manufacturing
Iso 9000
21 Cfr Part 11
Spreadsheet Validation
Medical Travel Facilitation
Online Teaching
Japanese Culture