Quality Control
Resume:
Sep **** - Present
Senior Quality Assurance Technician
Responsible for monitoring and maintaining quality and compliance targets.
Directing and traing QA technicians and inspection personnel Authored validation deliverables, such as master plans, IQ, OQ, PQ protocols & reports, as well as test & assembly procedures Perform functional, hazard analysis, reliability, and failure analysis of medical equipment test fixturing
Processing documentation and drawing changes via the ECR / ECO process
Ensuring non-conforming products are identified and placed on restriction
Representing QA for MRB meetings
Training production personnel on new and revised procedures Performing first article inspections - dimensional, visual & electrical
Responsible for maintaining Lab test area to 5S standards Internal and vendor quality auditing to ISO 13485 / 21 CFR Part 820
Performing final release of product before shipment Provide support for FDA, CSA and UL audits
Responsible for applying LEAN manufacturing techniques to the production lines
BAYER HEALTHCARE
EMPLOYMENT
PROFILE
A highly efficient, methodical and talented quality assurance technician who has considerable experience of developing and implementing effective quality processes and structures in a medical device manufacturing enviroment. Strong auditing and validation experience, and a backround of achievement in supporting all levels of management.
Looking for a company which will challenge my problem solving skills and allow me to continue to develop my knowledge and potential.
Corey W
Megon
Contact
********@*******.***
29 Boulder Drive
Pittsburgh, Pa 15239
Mar 2000 - Aug 2001
Quality Control Inspection Supervisor
Supervised incoming inspection personnel
Performing in-process and final inspection of PCBs to IPC 610 standards
Computer entry of inspection data to produce reports Training inspectors and technicians
LIFECOR, INC
Sep 1998 - Mar 2000
Quality Control Supervisor
Performed inspection and test of PCBs, interface panels, sub- assemblies and power supplies
Design and assembly of test fixtures
Database control of quality related documentation
Supervision of calibration and inspection technicians Drafting quality procedures to meet required specifications Participated in internal audit program
VECTRAN CORPORATION
Jul 1994 - Mar 1998
Computer Operator
Database backup of patient and financial information Generate summary reports for department managers
Maintenance and support of computers and printers
MONSOUR MEDICAL CENTER
Feb 1988 - Mar 1992
Quality Control Manager
Manage quality system and inspection department
Trained technicians and inspectors
Calibration and repair of measuring and test equipment Performing internal process audits
Representing the company in aerospace and nuclear audits Calibration and repair of measuring and test equipment WESTMORELAND MECHNICAL
TESTING AND RESEARCH
Jun 1986 - Jan 1988
Service/Installation Technician
Service and installation of hard wire and wireless security, fire protection, access and CCTV systems for residential and commercial applications
GREINER SECURITY, INC
GATEWAY TECHNICIAL INSTITUTE May 1984 - Jun 1986
Associates Degree - Specialized Electronic
Technology
EDUCATION
SKILLS
Certified Auditor - ISO 9001,
ISO 13485
Proficient in Microsoft Office
Able to use measurement
tools - calipers, scales,
micrometers, DVM
Dec 2013
For achieving significant
savings to support the VIP
program with a production
labor savings of 257K annually.
PRESIDENT'S TEAM GOLD
AWARD
Apr 2007
For achieving outstanding
quality improvement results
through successful
application of team
processes. - DHR Error
Reduction Team
PRESIDENT'S TEAM GOLD
AWARD
ACCOMPLISHMENTS
REFERENCES AVAILABLE UPON REQUEST
Contact this candidate