Name variants:
Edgar Balcos,
Edmund Balcos,
Edward Balcos,
Edwin Balcos
Last updated May 02, 2024
Contact Information
Workplace
Director, Quality Systems
Irvine, CA
Industry
Medical Devices, Noncommercial Research Organization
Colleagues
Work History
Director, Quality Systems
Orange County, California Area
ISO 13485 QMS, Supervise Staff, Project Managment, FDA PMA Modular Submission, R&D Product Development - Design Controls, CE Marking of New Product Line
from Sep 2011
Quality Systems Manager
Quality Systems Manager - maintained Acacia's quality management system to ISO 13485 requirements.
Jul 2010 — Sep 2011
Director, Operations
Manage and direct entire daily business operations including purchasing, receiving, receiving inspection, inventory management, inventory control, final inspection, packaging, and shipping o...
Feb 2010 — Jun 2010
Director, Quality Systems
Developed, initiate and implement all elements of CFR Part 820 and ISO 13485 quality systems. Directed compliance activities of manufacturing, operations and R&D. Prepared company's qual...
Aug 2008 — Aug 2009
Manager, Quality Systems
Quality Systems Manager that implemented and maintained Visiogen's quality management system to ISO 9001 and ISO 13485 requirements.
May 2002 — Aug 2008
Quality Engineer
Staff Quality Engineer of sunglass product which included manufacturing processes of frames, lens, and goggles.
Jan 2002 — May 2002
Senior Quality Engineer
Senior Quality Engineer for Intralase's femto second laser and patient interface kit.
Jan 2001 — Dec 2001
Senior Quality Engineer
Lead Quality Engineer for Radiance Medical Systems beta radiation catheter.
Mar 1999 — Jan 2001
Sr. Quality Engineer
Quality Engineering support of the Shiley tracheostomy tube product line.
Jul 1993 — Feb 1999
Quality Engineer
Served as Quality Engineering resource for coated dental implant product line.
Aug 1991 — Jul 1993
Education
Occupations
Executive
Director
IT Professional
Systems Manager
Operations Manager
Computer Systems Administrator
Skills
Iso 13485
Quality System
Fda
Medical Devices
Design Control
Ce Marking
Quality Control
Quality Assurance
Capa
R&D
Iso 14971
Iso 9000
Product Development
Validation
Regulatory Affairs
Gmp
V&V
Quality Auditing
Lean Manufacturing
21 Cfr Part 11
21 Cfr
Iso
Six Sigma
Biomedical Engineering
Spc
Leadership
Change Control
Design of Experiments
Cqa
U.s. Food and Drug Administration
Pma
Auditing
Fda Gmp
Medical Device Directive
Certified Quality Auditor
Research and Development