Chris Pugh

Sr. Quality Consultant

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Quality System expert with over 23 years of experience in Quality Systems Management, Product Quality and Environmental Management. Additional experience includes:  ISO 13485 certified Lead Auditor, ISO 9001, ISO/TS 16949, ISO14001, ESD S20.20 and 21 CFR Part 820, FDA Warning Letter response, Consent Decree, Remediation/Work-Stream Lead.

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Experience

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• Responsible for Operation Quality Assurance including Receiving Inspection, In-process quality, Quality Engineering and Product Release. Sr. Manager, PQ - Philips Medical Systems  

• Work stream lead of various cross functional team to improve deficiencies in quality processes such as complaints, backlogs, increased capacity & efficiency,  QMS recertification and develop an NCR Process - Sr. Quality Systems Manager -Philips Medical Systems 

• Manage, investigate, plan and implement improvements to the quality system such as CAPA, Design Controls and Audit Programs - Quality Assurance Chief - Terumo Cardiovascular Systems

• Responsible for managing the quality system elements such as CAPA, NCR, Auditing, Change Control, Records, validations, Risk Management, post-market surveillance and lead auditor - Quality Systems / Environmental Engineering Manager - Jabil Inc.

 

Education

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• Bachelor of Arts - University of Michigan

 

Continuing Education

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• Root Cause Analysis training (Tom Weaver)

• Sig Sigma Training

• ISO 13485 / ISO 9001 RABQSA certified FDA Regulated Industries Lead Auditor

• QSR (Medical) Interpretation and Implementation

• Internal auditor training for FDA Regulated Industries

• ISO 9001:2000 Internal auditor certification

• ISO 14001: 2004 Internal auditor certification

• ISO/TS 16949: Internal auditor certification

• Reengineering training

• Continuous Improvement

• RAB approved ASNI/ISO/ASQ 9001-2000 Transition Training

• Train the Trainer

• HAZWOPER certification

• Hazardous Waste Generator Training

• KT Root Cause Training