Richard Chong, P.Eng., CM2-C
Quality Lead at Hyivy Health- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Stephanie Hart
Richard quickly learned our products, customers and projects. He managed multiple projects for multiple customers, balancing their needs and priorities as well as expertly communicating with the customers. Richard was also a key contributor to improving and documenting our Project Management processes. He is friendly, easy to work with, and was a valued member of our team!
Evgeny Fraimovich
From day one Richard proved to be very effective managing complex projects. He quickly learned nuances of the business, connected with customers and development teams. His positive attitude, outstanding work ethics, professionalism made the teams cooperate and projects thrive. Richard would make any work place a better place.
Stephanie Hart
Richard quickly learned our products, customers and projects. He managed multiple projects for multiple customers, balancing their needs and priorities as well as expertly communicating with the customers. Richard was also a key contributor to improving and documenting our Project Management processes. He is friendly, easy to work with, and was a valued member of our team!
Evgeny Fraimovich
From day one Richard proved to be very effective managing complex projects. He quickly learned nuances of the business, connected with customers and development teams. His positive attitude, outstanding work ethics, professionalism made the teams cooperate and projects thrive. Richard would make any work place a better place.
Stephanie Hart
Richard quickly learned our products, customers and projects. He managed multiple projects for multiple customers, balancing their needs and priorities as well as expertly communicating with the customers. Richard was also a key contributor to improving and documenting our Project Management processes. He is friendly, easy to work with, and was a valued member of our team!
Evgeny Fraimovich
From day one Richard proved to be very effective managing complex projects. He quickly learned nuances of the business, connected with customers and development teams. His positive attitude, outstanding work ethics, professionalism made the teams cooperate and projects thrive. Richard would make any work place a better place.
Stephanie Hart
Richard quickly learned our products, customers and projects. He managed multiple projects for multiple customers, balancing their needs and priorities as well as expertly communicating with the customers. Richard was also a key contributor to improving and documenting our Project Management processes. He is friendly, easy to work with, and was a valued member of our team!
Evgeny Fraimovich
From day one Richard proved to be very effective managing complex projects. He quickly learned nuances of the business, connected with customers and development teams. His positive attitude, outstanding work ethics, professionalism made the teams cooperate and projects thrive. Richard would make any work place a better place.
Credentials
-
ISO 13485:2016 Medical Devices Internal Auditor
SAI GlobalJun, 2022- Sep, 2024 -
ISO 13485:2016 Medical Devices Internal Auditor
SAI GlobalJun, 2022- Sep, 2024 -
CAPA, Nonconformance, and Complaints
Greenlight GuruJan, 2022- Sep, 2024 -
CM2-07 Optimization of Core Business Processes
Institute for Process ExcellenceDec, 2021- Sep, 2024 -
CM2-08 Sustainable Organizational Transformation
Institute for Process ExcellenceDec, 2021- Sep, 2024 -
Biocompatibility Evaluation for Device Submission
Greenlight GuruSep, 2021- Sep, 2024 -
Building a Regulatory Strategy Executive Summary
Greenlight GuruSep, 2021- Sep, 2024 -
Building the Business Case
Greenlight GuruSep, 2021- Sep, 2024 -
CM2-05 The Complexities of Lifecycle Sustainment
Institute for Process ExcellenceSep, 2021- Sep, 2024 -
CM2-06 Enterprise CM2 Implementation
Institute for Process ExcellenceSep, 2021- Sep, 2024 -
CM2-C Comprehensive Certification
Institute for Process ExcellenceSep, 2021- Sep, 2024 -
Design Control 101
Greenlight GuruSep, 2021- Sep, 2024 -
How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch
Greenlight GuruSep, 2021- Sep, 2024 -
Market Access Strategy
Greenlight GuruSep, 2021- Sep, 2024 -
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
Greenlight GuruSep, 2021- Sep, 2024 -
Strategies to Limit Project Timeline and Cost in Medical Devices
Greenlight GuruSep, 2021- Sep, 2024 -
The Importance of Product Classification to Regulatory Strategy
Greenlight GuruSep, 2021- Sep, 2024 -
The Most Common Mistakes Health Tech Founders Make When Pitching
Greenlight GuruSep, 2021- Sep, 2024 -
UDI and Device Registration, Another Launch Checkbox
Greenlight GuruSep, 2021- Sep, 2024 -
US FDA 101
Greenlight GuruSep, 2021- Sep, 2024 -
Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare
Greenlight GuruSep, 2021- Sep, 2024 -
CM2-03 Fundamentals of Change Management
Institute for Process ExcellenceAug, 2021- Sep, 2024 -
CM2-04 The CM2 Enterprise Closed Loop Change Process
Institute for Process ExcellenceAug, 2021- Sep, 2024 -
Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018
Greenlight GuruJun, 2021- Sep, 2024 -
Documenting Risk Management to Meet Requirements of ISO 14971:2019
Greenlight GuruJun, 2021- Sep, 2024 -
How Risk Management Can Help Drive Innovation
Greenlight GuruJun, 2021- Sep, 2024 -
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
Greenlight GuruJun, 2021- Sep, 2024 -
How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns
Greenlight GuruJun, 2021- Sep, 2024 -
Implementation of the Risk Management Board for New Product Introduction and Post Market Surveillance
Greenlight GuruJun, 2021- Sep, 2024 -
Protecting your Data from Risk: To, From, and In the Cloud
Greenlight GuruJun, 2021- Sep, 2024 -
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
Greenlight GuruJun, 2021- Sep, 2024 -
What is the Best Way to Structure a Risk Management File
Greenlight GuruJun, 2021- Sep, 2024 -
What to do when FMEA is Not Sufficient Anymore
Greenlight GuruJun, 2021- Sep, 2024 -
Who Owns Risk Management and How Does it Impact the Business?
Greenlight GuruJun, 2021- Sep, 2024 -
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
Greenlight GuruMar, 2021- Sep, 2024 -
CM2-02 Requirements and the CM2 Baseline
Institute for Process ExcellenceMar, 2021- Sep, 2024 -
Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process
Greenlight GuruMar, 2021- Sep, 2024 -
How to Create Medical Device Labels per EU MDR
Greenlight GuruMar, 2021- Sep, 2024 -
How to Maintain a QMS Compliant to MDR & IVDR
Greenlight GuruMar, 2021- Sep, 2024 -
How to Meet Cybersecurity Requirements of EU MDR & IVDR
Greenlight GuruMar, 2021- Sep, 2024 -
How to Prepare for Common MDR Audit Pitfalls
Greenlight GuruMar, 2021- Sep, 2024 -
Implementing and Maintaining Changes to SaMD Under MDR
Greenlight GuruMar, 2021- Sep, 2024 -
IpX-20 Universal Document Control
Institute for Process ExcellenceMar, 2021- Sep, 2024 -
Risk Management According to EU MDR or ISO 14971
Greenlight GuruMar, 2021- Sep, 2024 -
Learning Microsoft Flow
LinkedInJan, 2021- Sep, 2024 -
SharePoint Online Essential Training: Beyond the Basics
LinkedInJan, 2021- Sep, 2024 -
SharePoint Online Essential Training: The Basics
LinkedInDec, 2020- Sep, 2024 -
Health to Business Bridge Program Certificate
Ontario Bioscience Innovation OrganizationAug, 2020- Sep, 2024 -
CM2-16 Foundational Principles for Optimizing the Digital Thread & Digital Twin
The Institute for Process ExcellenceApr, 2020- Sep, 2024 -
Aras Configuring Solutions 11
Aras CorporationJul, 2018- Sep, 2024 -
Aras PLM Essentials 11
Aras CorporationMay, 2018- Sep, 2024 -
Implementing APQP/Product Realization - APQP, Control Plan and PPAP
AIAGAug, 2006- Sep, 2024 -
CATIA V4
Maverick Solutions Inc.May, 2002- Sep, 2024 -
CATIA V5
Maverick Solutions Inc.May, 2002- Sep, 2024 -
Leadership Skills
Humber CollegeApr, 2001- Sep, 2024 -
Supervisory Skills
Canadian Management CentreMar, 2000- Sep, 2024
Experience
-
Hyivy Health
-
Canada
-
Wellness and Fitness Services
-
1 - 100 Employee
-
Quality Lead
-
Aug 2021 - Present
Innovative medical device start-up creating the first intelligent and holistic pelvic rehabilitation device for women to help alleviate pelvic health symptoms.• Implementing medical device quality management system per ISO 13485• Implementing risk management plan per ISO 14971
-
-
Quality Consultant
-
Jan 2021 - Aug 2021
-
-
-
CaseBank Technologies Inc., A Division of ATP
-
Canada
-
Software Development
-
1 - 100 Employee
-
Project Manager
-
Sep 2018 - Jan 2020
-
-
-
BOMBARDIER
-
Canada
-
Aviation and Aerospace Component Manufacturing
-
700 & Above Employee
-
PLM Engineering Specialist / Project Manager
-
Feb 2011 - Aug 2018
-
-
Methods Engineer / Industrial Engineer
-
Apr 2007 - Feb 2011
-
-
-
Origin International Inc.
-
Canada
-
Software Development
-
1 - 100 Employee
-
Consultant
-
Jan 2006 - Mar 2007
-
-
-
-
Applications and Quality Manager
-
Aug 2002 - Jun 2005
-
-
-
-
Manager
-
Oct 2001 - Aug 2002
-
-
-
-
Methods Analyst / Six Sigma Green Belt
-
Apr 1996 - Sep 2001
-
-
-
-
Costing & Estimating Coordinator
-
Aug 1994 - Jan 1996
-
-
Education
-
1989 - 1994
University of Waterloo
Bachelor of Applied Science (BASc)
Community
