CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Lee Simanski, Principal Quality Systems Engineer

Boston Scientific

About

Lee Simanski has over 25 years of experience working for Boston Scientific in Arden Hills, Minnesota.  He is currently a Principal Quality Systems Engineer with primary responsibilities for the audit program.   In his 25 years at Boston Scientific, Lee has held various positions of increasing responsibility across Post Market Support, Quality Assurance, and Compliance.  Boston Scientific Arden Hills is home to the Rhythm Management group, which develops and markets products that treat irregular heart rhythms and heart failure, and protect against sudden cardiac arrest.  Lee participated in the site’s second MDDAP appraisal in December 2018 as an Embedded Team Member and has been trained as a Certified CMMI Associate.
 

SPEAKER PRESENTATION

Panel: How to be an Appraiser in MDDAP

Conference Track: Improving Capability in the Medical Device Industry

The FDA’s collaborative pilot program intends to simplify regulatory requirements for medical device makers who are committed to quality manufacturing practices. The pilot program leverages CMMI V2.0 to assess medical device manufacturers against industry best practices and offer improvement opportunities. Find out more about the tailored application of CMMI V2.0 and what it takes to get involved.