John Downing Email & Phone Number

• Hands-on Quality Operations Manager, who has directed pioneering work in diverse industries such as medical device, Department of Defense, automotive, nuclear, and bio-energy; Core philosophy – “Quality is not a department, but an organizational endeavor”• Cross-functional lean manufacturing team leader with significant experience identifying and defining customized corporate quality matrixes which measure systemic effectiveness/efficiencies in real time; Cross-functional, quality team lead and manager adept at synchronizing corporate strategy with Quality policies and standards; conducted peer review audits at critical points to aid in harmonization of corporate quality management systems (QMS)• Develop peer review processes at critical audit point matrixes that: Chronologically drive corporate quality management initiatives from the white sheet through final product shipment, assuring peer review at critical junctures points within the QMS.  Manage and provides Lean Teams with sound corporate and systematic problem-solving methodologies, in identifying, prioritizing, communicating, and resolving corporate quality issues._________________________________________________• Certified Master Black Belt, Green Belt and Orange Belt • ANSI /ISO/ASQ / Q9000 / Q9001 / Q9004 – 2008• FDA Standards QSR\EN ISO 13485 – 2003/8• Part 11 Fully Protected Electronic QMS • 21 CFR Part 820 (820 30, 72, 210, 211, and 11.etc)• 21 CFR Part 807 510K, 21 CFR Part 814 PMA, 21CFR Part 812 IDE• ISO 14971 – Risk Management• IEC/ISO 17025 Metrology labs standards • ISO/ESD 2020 Electro Static Discharge • ISO 14001, 2004; EMS Requirements• ISO/TS 16949 Automotive Standards formally QS9000 FMEA PPAP Protocols Control plans Gauge R&R etc• Line set up Design For Manufacturability (DFM)• IQ –Installation Qualifications, OQ – Operational Qualifications, PQ – Process Qualifications, PV&V Process Verification and Validation – Prd.V&VSpecialties: Serve as an expert to multiple industries in writing and certifying Corporate Quality Management SystemsBuilt an ongoing electronic database containing my life’s works – documents are used to aid in application effectiveness efficiencies of quality management systemsGMQS is also part of the global harmonization group for ease and use of the ISO 9000 – 2008 and 13485 – 2003/8 standards

Listed skills include Quality Management and Design.