Paul Richards

QMS Auditor

Role
Audit Program Manager at Malkan Solutions Llc
Location
Milwaukee, WI, US
LinkedIn followers
500 followers
Finance & AccountingView LinkedIn profile

About Paul Richards

Senior Member: American Society for QualityASQ Certified Manager of Quality / Operational ExcellenceASQ Certified Quality AuditorPECB Certified ISO 13485:2016 Lead AuditorPECB Certified ISO 9001:2015 Lead AuditorGE Healthcare Lead AuditorGE Healthcare Calibration Auditor ISO 17025Quality Management Systems Specialties: Strong working knowledge of FDA GMP, ISO 13485 and ISO 9001 quality system standards. Hands on experience with quality audits and customer complaint investigation.

Experience

  1. Audit Program Manager

    Malkan Solutions Llc

    Aug 2023 — Present · Brookfield, WI, US

Education

  • Milwaukee Area Technical College

    Associate in Applied Science, Printing and Electronic Publishing

    1997 — 2000

  • Ottawa University

    Bachelor, Management

    2003 — 2006

Skills

  • Medical Devices
  • Capa
  • Iso 9000
  • Iso 13485
  • Continuous Improvement
  • Iso
  • Business Process Improvement
  • Fda
  • Quality System
  • Value Stream Mapping
  • Process Improvement
  • Auditing
  • Fmea
  • Corrective and Preventive Action (Capa)
  • Spc
  • Iso 9001
  • Minitab
  • Cqa
  • Quality Management
  • Supplier Evaluation
  • Calibration
  • Root Cause Analysis
  • Six Sigma
  • Quality Auditing
  • Dmaic
  • Operational Excellence
  • Quality Control
  • Gmp
  • Iso Standards
  • U.s. Title 21 Cfr Part 11 Regulation
  • Supplier Quality
  • Kaizen
  • Quality Assurance
  • Lean Manufacturing

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Paul Richards — Audit Program Manager at Malkan Solutions Llc in Milwaukee, WI, US | Unifers