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
Manufacturing & ProductionView LinkedIn profile

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

  1. Quality Systems Manager

    EBR Systems, Inc.

    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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Nate Clark — Quality Systems Manager at EBR Systems, Inc. in San Jose, CA, US | Unifers