Nate Clark
Medical Device QMS / Program Management / Product Compliance
- Role
- Quality Systems Manager at EBR Systems, Inc.
- Location
- San Jose, CA, US
- LinkedIn followers
- 500 followers
About Nate Clark
Proven leadership in Program Management addressing emerging worldwide medical device regulations such as EU MDR, FDA UDI, ISO 13485, and MDSAP- Organized and lead support teams for FDA and Notified Body Audits- Experienced as a Lead Auditor, in NC/CAPA resolution, in PLM/Excel/MS Project systems, and in QMS procedure/process development to maintain regulatory compliance- SME for environmental compliance to RoHS, REACH, California Prop 65, EU MDR hazardous substances, and sustainability requirements such as Brazil Eco-design, End-of-Life management.
Experience
Quality Systems Manager
Feb 2024 — Present · Sunnyvale, CA, US
Responsible for the growth and compliance of a start-up medical device Quality System, to include Doc Control, CAPA, Internal Audit, and quality planning- Direct management of the move from a paper-based organization to an electronic process-centric model.
Education
University of Wisconsin-Madison
BSEE, Electrical and Computer Engineering
1994 — 1997
Old Dominion University
Masters, Engineering Management
2002 — 2004
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