Christine McComb
Quality Management Systems
Waterdown,ON
Summary
Quality Management System expert including certified Lead Auditor (ISO 13485:2016, ISO 9001:2015, MDSAP and TS 16949) experience in various industries from automotive to medical device. Project Manager complex global projects. Holds a degree in Mechanical Engineering. Effective Project Manager demonstrating exceptional interpersonal skills and analytical thinking. Adeptly navigates and addresses individual strengths and weaknesses developing a collaborative team approach to problem solving, ensuring on going compliance to all Quality Management System (QMS) requirements while continuously improving processes.
Overview
11
11
years of professional experience
3
3
Certification
Work History
Global Audit Manager
SCIEX
01.2017 - 12.2023
- Ensured company remained compliant to Quality Management System (QMS) and that QMS met all requirements and continuously improved. Global medical device company, Canada, US and Singapore. Scope included R&D, manufacturing, service. No major nonconformances at notified body audits throughout tenure.
- Coached and mentored all Subject Matter Experts and Process Owners to understand requirements of QMS. Collaborated to ensure continuous improvement while maintaining compliance.
- Liaison for Notified Body audits; scheduled audits, prepared each site developing risk mitigation plans for any areas of concern, and responded to any audit findings.
- Successfully managed certification upgrade for both ISO 9001:2015 and ISO 13485:2016 and addition of 2 new sites to both ISO certificates;
- Developed global internal audit process and corresponding SOPs, standardized reporting documentation including risk assessment of findings. Developed and deployed internal auditor qualification program.
- Collaborated with all SMEs and Process Owners to ensure all audit findings were resolved at root cause level, initiating CAPAs based on risk, validating all corrective and preventive actions, using sound judgement and critical thinking
- Led continuous improvement of audit program through implementation of QMS software, automating audit process
- Identified, developed, and tracked key performance metrics, KPIs, on all audit data. Data Analysis
- Lead Auditor for QMS processes including but not limited to Supplier Controls, Design Controls, Manufacturing, Service and Complaints.
Project Manager
SCIEX
10.2020 - 12.2022
- Lead interdisciplinary global team to configure and implement new Quality Management Software tool to be used company wide. Efforts were recognized by senior leadership
- Successfully lead team to configure, validate and implement new Document Control module including transition from old software, MasterControl to new software, SmartSolve. Completed in less than 1 year.
- Communicated and organized change management of Document Control software to global organization, guided by Prosci change management principles.
Quality Specialist
SCIEX
01.2015 - 01.2017
- Transformed SCIEX global QMS from requirement based QMS to process based QMS and successfully achieved ISO 9001:2015 certificate for all 5 SCIEX sites
- Developed and rolled out training for all new SCIEX associates on global QMS requirements including GMP. Created QMS training with Articulate to be launched on Learning Management System
- Process mapped all QMS processes and conducted GAP analysis to ensure all ISO requirements were met. Created action plans to close any gaps. Collaborated with Subject Matter Experts and Process Owners to close gaps
- Guided process owners to develop adequate KPIs were available to ensure effective monitoring of processes.
Training Program Lead
IMAX
01.2013 - 01.2015
- Developed training strategy for Technical Services Department, 65 Global Field Technicians
- Created on-line learning modules to provide accessible education to team resulting in consistent methods of performing duties.
Process Improvement Specialist
IMAX
01.2013 - 01.2015
- Established New Product Development process, process mapping inputs and outputs at defined stages of product development. Loosely defined deliverables at each stage of development.
Project Manger
Husky Injection Molding
Project Specialist
Husky Injection Molding
Supplier Quality Engineer
Husky Injection Molding
Quality Team Leader
Husky Injection Molding
Education
Bachelor of Science (BSc) - Mechanical Engineering
University of Akron
Akron, Ohio08.1983
No Degree - Nursing
Case Western Reserve University
Cleveland, Ohio12.2005
Skills
- Quality Management System Expert
- Lead Auditor/ Internal Auditor
- Trainer/ Training / Mentor
- Strategic Analytical Thinker
- ISO 13485:2016
- ISO 9001:2015
- Problem-Solving
- Team Collaboration
- Project Management
- Document Management
- Supplier Quality
- Process Mapping
- Continuous Improvement
- Document Control/ Standard Operating Procedures
Certification
- Lead Auditor, ISO 9001:2015, SAI Global, C307248
- Lead Auditor, ISO 13485:2016, TPECS, 8497902 155596 BSI
- Lead Auditor, MDSAP, Oriel Stat, 2023-12-01
- AIAG Lead Auditor, TS 16949:2002 Supplier Auditor Certification, PL/RAB/TS/D12/6/6/08
- Certified Quality Engineer, American Society of Quality Engineers, 5092
Languages
English
Native or Bilingual
Timeline
Project Manager
SCIEX
10.2020 - 12.2022
Global Audit Manager
SCIEX
01.2017 - 12.2023
Quality Specialist
SCIEX
01.2015 - 01.2017
Training Program Lead
IMAX
01.2013 - 01.2015
Process Improvement Specialist
IMAX
01.2013 - 01.2015
Bachelor of Science (BSc) - Mechanical Engineering
University of Akron
No Degree - Nursing
Case Western Reserve University
Project Manger
Husky Injection Molding
Project Specialist
Husky Injection Molding
Supplier Quality Engineer
Husky Injection Molding
Quality Team Leader
Husky Injection Molding