
Shahn Jafari
Key leadership roles: · Obtained ISO 9001 & 9002 certifications for two companies, multi sites (Furon & Prudential).... | Irvine, California, United States
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Shahn Jafari’s Emails sa****@pa****.net
Shahn Jafari’s Phone Numbers No phone number available.
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Shahn Jafari’s Location Irvine, California, United States
Shahn Jafari’s Expertise Key leadership roles: · Obtained ISO 9001 & 9002 certifications for two companies, multi sites (Furon & Prudential). · Represented Quality Engineering & Regulatory Compliance in creating the Design Input Requirement document (DIR) & design Development Planning. · Specified various Environmental Monitoring systems for Cleanrooms. · Monitored Biological & Contamination levels in Cleanrooms. · Sterilization validation using Gamma, E-Beam, Hydrogen Peroxide, Steam, and ETO. · Participated in Design Review meetings including third party vendors and contract mfg. · Supported quality improvement projects throughout the life cycle of products including validation, design for manufacturability, and design transfer to contract Mfr. per EN & ISO (for JnJ & Terumo). · Developed Validation Master Plans, test scripts, and executed the protocols (e.g. IQ/OQ/PQ). · Brainstormed in numerous environments to develop new/updated Quality Plan, Hazard Analyses, Risk Assessment, and FMEA (Design and Process) documents. · Actively supported Process Eng., IT, Regulatory Compliance, and Manufacturing in developing & marketing of high quality, reliable and cost effective products. · Customer focused with analytical problem-solving skills in identifying, prioritizing, communicating, and resolving quality issues. · Supply Chain management, partnership & development. · Regulated industry expertise over 14 years. Participated in pre-FDA, FDA, & post-FDA audits. Specialties: I possess a diverse Engineering background, having served various manufacturing environments including: · Biotech Clinical Research · Pharmaceutical Labs · Medical Device Mfg. · Aerospace · Automotive Tier-II · Electronics & Electro-Mechanical Contract Assembly & Mfg. · Contamination Controls & Cleanrooms
Shahn Jafari’s Current Industry Bbraun Medical
Shahn
Jafari’s Prior Industry
Southwestern Industries
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Swedlow
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Furon Medical Mechanical Seal Division
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Prudential Cleanroom Laboratories
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Laguna Engineering
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Schering Plough Health Care Products
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Chiron
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Amgen
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Baxter Bioscience
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Advanced Sterilization Products
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Terumo Cardiovascular Systems
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Bbraun Medical
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Work Experience

Bbraun Medical
Project Lead/Mgr.
Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Terumo Cardiovascular Systems
Validation Specialist
Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Advanced Sterilization Products
Component Engineer
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Amgen
Validation Specialist
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Baxter Bioscience
Validation Specialist
Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Schering Plough Health Care Products
Validation Specialist
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)
Chiron
Project Management
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)
Laguna Engineering
PROJECT MANAGER / ENGINEERING SPECIALIST
Sat Sep 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Prudential Cleanroom Laboratories
CORPORATE QUALITY MANAGER
Mon May 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Sep 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Furon Medical Mechanical Seal Division
QA ENGINEERING SUPERVISOR
Fri May 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time)
Swedlow
Sr. QA ENGINEER
Tue Nov 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri May 01 1992 00:00:00 GMT+0000 (Coordinated Universal Time)
Southwestern Industries
INDUSTRIAL ENGINEER / PROGRAM MANAGER / QA MANAGER
Sat Jun 01 1985 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Nov 01 1988 00:00:00 GMT+0000 (Coordinated Universal Time)