“Karen is a medical diagnostic regulatory expert and whether its CPSA, CAPS, ISO, FDA, MDR, or IVD, she can help! When she says she'll do it, consider it done.”
About
Whether it is ‘coaching the business’ for improved quality practices through observation and assessment or coaching an individual to identify areas where a new and different action may produce a new result, transformation is the outcome. Visit me at karenmatthews.ca
I have a diverse professional background in retail management, hospitality management, and have spent over 35 years in the technical analytical laboratory, with experience in Histopathology, Pre-examination, Safety, Quality Assurance and Regulatory Affairs. I also achieved my Lead Auditor ISO13845 certificate in 2021.
I also am a certified coach, which includes:
2009 Trained and Certified to facilitate The Passion Test by Janet Bray Attwood and Chris Attwood
2010 Advanced Training and Certification The Passion Test for Kids
2010 Advanced Training and Certification The Passion Test for Business
2011 Life Coach Certification
2011 Certified to teach The Love Course and The Happiness Generator Course - Marci Shimoff
2012 Trainer and Facilitator of Workshops for The Leadership Challenge 4th Edition - Kouzes and Posner and the Student Leadership Challenge
I am a former award winning Toastmasters, with a passion for speaking, teaching and mentoring others.
I am an avid Life Long Learner and am often taking an eclectic mix of on-line University courses on Psychology, Sociology, Leadership, Innovation and Change Management. In my spare time I enjoy camping, and exploring (especially rock hounding), and as an Artisan, I create beautiful hand crafted wire wrapped crystal and stone jewelry designs, some of which are hosted at a local art gallery.
Live, Laugh, Love! ~ Passionately!
Formal Education:
Southern Alberta Institute of Applied Science and Technology – Medical Laboratory Technology CSMLS Canadian Society for Medical Laboratory Science (CSMLS) certification and licensure
Almeda University BSc (Major in Environmental Health and Safety Distinction).
Rochville University BA (Major in Quality Management) Distinction Strategic Management, Award of Excellence Quality Management
ISO 13485:2016 Lead Auditor Certification January 2021
Contributions
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What are the best ways to lead and inspire others to follow quality standards?
Set the expectation that your organization can be "the best of the best" and that happens with continuous improvement. Celebrate the "wins"! Celebrate the opportunities for improvement (OFIs) as they are a place to recognize where the team can come together and do something in a different way for a better outcome. Involve the team members in audits and assessments as that is how they learn to find those OFIs.
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How do you use quality document templates and checklists effectively?
We use procedures but rather than a work instruction we have an attachment as a Quick Reference that can be used as a quick step guide at the bench. This insures when the procedures are revised or updated the attached QR gets updated in tandem, both are related by date and version. It works for us
Activity
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We are thrilled to announce a major milestone in our journey at Syantra Inc. With the support of visionary investors, we’ve successfully raised $4.9…
We are thrilled to announce a major milestone in our journey at Syantra Inc. With the support of visionary investors, we’ve successfully raised $4.9…
Liked by Karen Matthews
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Mammogram reports will now include breast density. While mammography can detect cancer most of the time, women with dense breasts may need other…
Mammogram reports will now include breast density. While mammography can detect cancer most of the time, women with dense breasts may need other…
Liked by Karen Matthews
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This finding is music to my ears! When will Pharmas realize they have missed golden opportunities for so many years!?
This finding is music to my ears! When will Pharmas realize they have missed golden opportunities for so many years!?
Liked by Karen Matthews
Experience
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KM Quality Consulting
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Licenses & Certifications
Recommendations received
14 people have recommended Karen
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On September 11th @ 11:00 am – 12:00 pm PT, Sean Secord is presenting an online talk called: "Embracing Technological Advances to Align with New &…
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If you are a healthcare professional with interest in innovation we look forward to seeing you there ! #healthtech #innovationforgood #nanotess
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Half of the Canadian delegation (13 of 26) attending Medical Fair Asia 2024 (Singapore) were from Alberta. Strong signs of sector growth and…
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