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The PEAK Team
Who We Are
Spencer Walker, MSc.
Founder & CEO
Spencer has his undergrad training in Biology with an emphasis in Human Diseases (Biology BS) from Utah Valley University, and as a Medical Device Development Specialist (Translational Medicine, MSc) at Cranfield University (England/ UK) and has over 26 years of experience in the medical industry, including 20 years as a Regulatory Affairs and Quality Executive and Consultant/Advisor in the area of Medical Device Regulatory/ Quality Compliance.
801-708-2238
Santosh Bhagat
Director of Quality
Santosh Bhagat is ASQ Certified Quality Engineer and Auditor has VP level quality assurance experience in the Medical Device industry. With experience in equipment qualification and process validation and CAPA execution, Santosh effectively manages QMS activities to ensure that only the highest quality of medical devices reach the customer.
978-853-6793
Meraleen Cain
Quality Auditor
As a recently retired BSI Notified Body Auditor, Meraleen has over 25 + years’ experience in Implementation, Development, Modification, Maintenance and Sustainability in various industries such as Medical Device, Biologics, Dental, Veterinary; Aerospace, Aeronautical, Nautical, Satellite, Anti-Air-Warfare, Ballistic Missile Defense Systems, Submarines, Nuclear, Composites, Commercial Airline Fasteners; Food Sciences; Recreational and Private Manufacturing. She also has extensive experience in a vast array of Management Systems pertaining to regulatory affairs / quality assurance /calibration /health, safety and environmental management Comprehensive experience performing 1st and 2nd Party Audits and verification of compliance (Domestic and International)
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