Russ Jopling

About Russ Jopling

I am a quality assurance engineer who specializes in ISO 9001 and ISO 15378 compliance, and the implementation and restructuring of corporate quality systems. I have extensive experience working in the medical device, calibration, customer service, regulatory and engineering industries.

Experience

1. Quality Assurance Engineer

   Mega Pumps Lp

   Mar 2014 — Present · Eatontown, NJ, US

   Responsible for Quality Systems throughout facility.• Audited on a weekly basis documentation and batch records.• Created Pareto Charts to track month-to-month process of internal audit findings.• Created key suppliers to ensure compliance with regulatory needs, including supplier surveys, supplier quality agreements and confidentiality agreements.• Upgraded calibration systems and created master calibration list, reducing costs by 10 percent.• Implemented and served as lead auditor for ISO 9001 and ISO 15378 compliance.• Responsible for company Drug Master File and updates to FDA.• Upgraded Incoming Inspection process for raw materials received in house.

Education

• DeVry University

  Associate's degree, Electronics Engineering Technology

• Middlesex College

  Associate's degree, Hotel and Restaurant Management

Skills

• Failure Mode and Effects Analysis (Fmea)
• Instrumentation
• Regulatory Affairs
• Iso 17025
• 21 Cfr Part 11
• Verification and Validation (V&V)
• Medical Devices
• Capa
• 5s
• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• 21 Cfr
• Iso
• Sop
• Fda
• Standard Operating Procedure (Sop)
• Spc
• Validation
• U.s. Title 21 Cfr Part 11 Regulation
• Design of Experiments
• Manufacturing
• Good Laboratory Practice (Glp)
• Cmi
• Change Control
• Cqa
• Iso 13485
• Quality System
• V&V
• Green Belt
• Lean Manufacturing
• Six Sigma
• Quality Auditing
• Fda Gmp
• Fmea
• Supplier Quality
• Iso 14971
• Quality Control
• Glp
• Gmp
• Auditing