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Management System Six Sigma

Location:
Cochrane, AB, Canada
Posted:
September 11, 2023

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Resume:

QUALITY EXECUTIVE

MCQI CQP (Charter Quality Institute), Certified ISO Lead Auditor, Certified Lean/Six Sigma Green Belt

Accomplished project quality professional with 15 plus years’ experience in construction projects from 5 million to 500 million dollars. Proven record in driving business-process improvements for both small and large companies in industrial and commercial construction as well as significant & successful contribution to a wide range of organizations including, but not limited to the following areas:

Lean Six Sigma process improvement

Development of ISO and Safety Audit programs to ISO 9001, 14001, COR, and ISO 17025

Commissioning

Supplier management

Turn Over

Work methods, ITP’s, Testing procedures and records (civil, mechanical, electrical, software, and manufacturing)

Bespoke Auditing and QC Software

Experience with various COT software

Construction projects in: Transportation, Energy, municipal improvements, residential, hospitals, police, and military facilities.

New Product Introduction (including QFD).

Risk Expertise ISO 31000

WORK EXPERIENCE

Manager, Quality System - Vitalis Technologies

October 2021 – March 2022

Key Accomplishments

Successful ISO certification to (ISO 9001:2015)

Development of a new product introduction process based on the Quality Function Deployment Model

Development of a Verification and Validation Process for instrumentation and process engineering

Development of processes including:

oDocumented Information

oDesign Controls

oContinuous Improvement

oTraining and Awareness

oManufacturing Controls (From Receiving to Product Release)

oInstallation and Service Controls

oMeasurement Analysis

oQuality Control

oRisk and Opportunities

Canada West Quality Manager – Pomerleau

December 2019 – May 2021

Key Accomplishments

Successful ISO recertification for region (ISO 9001:2015)

Maintenance of the ISO program for Western Canada in Commercial Building

Responsible for all QA of projects in Alberta and British Columbia (Calgary region, Fort Murray region, Wainwright, Coaldale, and Burnaby)

Responsible for reviewing all subcontractor quality control (ITP’s, Inspection Checklists, and third-party test and inspection)

Responsible for performing site and project audits

ITP Development and reviews including NDE (civil, mechanical/structural/Electrical/HVAC)

Responsible for training and mentoring project QA staff

Responsible for Corporate Quality and Safety scorecards

Commissioning and startup of numerous construction projects including residential, lift stations, recreational facilities, and police and military facilities.

Manager, Management System - Zephyr Sleep Technologies

January 2018 – February 2019

Key Accomplishments

Successful ISO recertification to (ISO 13485 for US and Canada)

Obtained regulatory approvals of software and hardware products for the US.

Maintenance of the ASL for regulated products and services from commodities to controlled product.

Oversaw Supplier audits and improvements – including suppliers in China, Canada, and other jurisdictions

Lean improvements in key operation and quality departments from 30 to 40 %.

Risk Register and Process Owner

Developed Health Safety and Security program including:

oCyber security program policies, programs, and penetration testing.

oSafe Work Procedures

Independent Quality Adviser and Consultant - Tidewater Midstream

April 2017 – August 2017

Key Accomplishments

Developed Vendor Prequalification and Second Party Audit program of Engineering Consultants for Integrity program (including ABSA).

ISO 9001 Based vendor qualification protocol development

oPerformed Audits of all Engineering Services companies.

oDeveloped QA/QC reviews of project turnover and vendor data requirements

EDUCATIONAL SABBATICAL – MBA program (Sept 2015- February 2017)

Senior Quality Adviser and Lead Auditor – TRANSCANADA

June 2011-July 2015

Key Accomplishments

Project manager for integration of the capital and operations management system programs for Keystone (US and Canada), Mexico; and Integrity programs to the following integrated management system components:

oSafety (ISO 18001); Environmental (ISO 14001); Security (ISO 27001); Design (ISO 9001:2008); and project quality (ISO 10005).

oCreated software which incorporated the standard operating procedures, specifications, and management system procedures.

Lead QMS adviser and auditor for all large projects (from proposal to commissioning):

Bronze Award for Planning and configuration of software system for audit surveillance and first party audits in all business processes of Capital Projects Management System (ISO 9001; 18001; 14001; and 55001).

Lead Auditor for 10 multimillion-dollar projects (from FEED to commissioning and cathodic protection).

oLead for National Energy Board Work Legal requirements and Auditing

Senior QA Management and ISO Auditing Consultant – GBPG CONSULTING INC.

July 2009- July 2012

Key Accomplishments (Clients Cenovus and Exxon Mobile) – Management System Consultant

Part of a team of Subject Matter Experts that implemented the COMS integrated management program (Cenovus Operations Management System), integrated management program.

Subject Matter lead Specific for the following programs in the IMS; reliability, emergency management, quality, and safety. These areas aligned to the following international standards:

oSafety (ISO 18001); Environmental (ISO 14001); Security (ISO 27001); Design (ISO 9001:2008); project quality (ISO 10005); and Asset Management (ISO 55001).

Other Relevant Industrial Experience

Quality and Regulatory Lead - General Electric Healthcare IT

Key Accomplishments

Verification and Validation of new products and enhancements.

Part of global team of quality and regulatory professionals that were tasked to set up an ISO 130485/FDA compliant business unit.

Six Sigma project for complaint handling

Establishment of risk based software development

Quality Manager – (Digital X-Ray Manufacturing) - Imaging Dynamics

(2004 – 2005)

Key Accomplishments

Successful Chinese certification body CQC that allowed multimillion-dollar sales to Chinese market.

Root Cause investigation resulted in discovering significant cost overrun and savings of approximately 1 million dollars in unapproved development work.

Qualification testing of new products for UL/CSA certifications opening up sales opportunities in domestic market.

Software Validation, Software Testing

Qualification testing to MIL-STD-810F, UL-60601, CSA 22.2, 60601

Verification and Validation of new products and new configurations of hardware and software.

Quality Manager (Class II Medical Device) - Centurion Medical Corporation

(2002 – 2004)

Key Accomplishments

Facilitated and lead the CE mark certification of existing products for export to Europe and the Middle East providing large marketing opportunity.

testing to UL-60601, CSA 22.2, 60601

Maintained ISO Registration

Lead Auditor

Other Areas of Expertise

Quality Assurance Management

Continuous Improvement

Corrective and Preventive Action

IMTE (Both hardware and software)

Six Sigma and Lean Improvements

ISO 9001 certification and implementation

New Product Introduction

Audit program development and administration

Certified ISO Auditor

Database Development

Supplier and Contract Management

Supplier Continuous Improvement

KPI and Score Card Development, Tracking, and Reporting

POST-SECONDARY EDUCATION and PROFESSIONAL DEVELOPMENT

MBA (William Howard Taft University)

Quality Management Diploma (U of M)

Bachelor of Arts (U of M)

Statistical Process Control Course (Red River Community College)

Materials and Processes (Southern Alberta Institute of Technology)

MPI Level I and II (Southern Alberta Institute of Technology)

LPI level I and II (Southern Alberta Institute of Technology)

Technical Communications Southern Alberta Institute of Technology

TapRoot Lead Investigator

Certified Lean Six Sigma Green Belt

Current Professional Memberships and Affiliations

Certified Quality Practioner (Charter Quality Institute)

Exemplar Certified ISO Lead Auditor



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