Jeff Zondag

About Jeff Zondag

An experienced manager who has experiences in auditing, LEAN/Six Sigma, quality system…

Experience

1. Senior Quality Engineering, Manager

   Accuray

   Dec 2011 — Present · Madison, WI, US

   At Accuray a Senior Quality Manager supports production, process, supplier, complaints and design controls which impact the Madison Facility. The position has budgetary, managerial, exempt and non-exempt employes. Directly responsible for all audit direction and interface at the Madison Operations Facility. Interfacing regulatory agencies include FDA, ISO, CE and internal auditing. Department coordinates supplier controls, design controls, P & PC, NCMR, CAPA and incoming goods inspection programs. This position reports to the director of quality, with a dotted line to the Plant Operations Manager.

Education

• Western Illinois University

  Master

  1980 — 1984

• University of Wisconsin-Stout

  Industrial Technology

  1976 — 1979

Skills

• Change Control
• Six Sigma
• Gxp
• Quality Auditing
• Lean Manufacturing
• Fmea
• Computer System Validation
• Quality System
• V&V
• Quality Assurance
• Design for Manufacturing
• Process Simulation
• Biomedical Engineering
• 21 Cfr Part 11
• Minitab
• Engineering
• Spc
• Dmaic
• Manufacturing Engineering
• R&D
• Iso
• Fda
• Fda Gmp
• Medical Devices
• Capa
• Iso 9000
• Supplier Evaluation
• Calibration
• Quality Control
• Gmp
• Process Engineering
• Ce Marking
• Apis
• Quality Management
• Continuous Improvement
• 21 Cfr
• Iso 13485
• Value Stream Mapping
• Validation
• Cleaning Validation