Mark Slonchka, P.Eng, PMP
Director of Quality and Regulatory Affairs at Thornhill Medical- Claim this Profile
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Bio
Experience
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Thornhill Medical
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Canada
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Medical Equipment Manufacturing
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1 - 100 Employee
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Director of Quality and Regulatory Affairs
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May 2020 - Present
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SCIEX
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United States
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Biotechnology
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700 & Above Employee
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Manager, Quality Engineering
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Aug 2016 - May 2020
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Meditech International Inc
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United States
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Medical Practices
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1 - 100 Employee
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Director of Product Development and Technical Services
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Jun 1998 - Aug 2016
• Over 18 years in the medical device industry with a strong background in quality, regulatory, product development, service and production. • Joined Meditech when the company had only basic approvals for one system in Canada. Achieved world-wide approvals and implemented the systems to support product quality, regulatory, service and production. • Brought multiple systems/products to market, involved from beginning to end; from initial planning with stakeholders, regulatory planning, determination of requirements, project management throughout the development phases, and the release of product to production. • Implemented a full medical quality system (ISO 13485) from scratch. Act as Meditech’s Quality Management Representative (QMR). • Responsible for regulatory affairs. Successfully submitted products to Health Canada, Europe (CE Mark), FDA (510(k)) and Australia. • In charge of the Production at Meditech. Manage the internal and external production, including planning, purchasing, manufacturing, and quality. • Worked in the customer service field for many years. Lead the Customer Service department at Meditech. • Licensed Professional Engineer (P. Eng) with the P.E.O. • Certified Project Management Professional (PMP) with PMI. • Excellent leadership qualities, project management skills and a high level of honesty and integrity. Show less
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The Laser Cure
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Medical Practices
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1 - 100 Employee
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Owner
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2006 - Jan 2011
The Laser Cure is a clinic that specializes in pain relief, accelerated healing and addiction assistance (i.e. Wounds, Fibromyalgia, Smoking Cessation, etc.) using Low Intensity Laser Therapy (LILT or Laser Therapy). Laser Therapy is an emerging medical technology which helps heal conditions better than traditional methods alone. The Laser Cure is a clinic that specializes in pain relief, accelerated healing and addiction assistance (i.e. Wounds, Fibromyalgia, Smoking Cessation, etc.) using Low Intensity Laser Therapy (LILT or Laser Therapy). Laser Therapy is an emerging medical technology which helps heal conditions better than traditional methods alone.
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Education
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Ryerson University
B. Eng, Electrical Engineering