Quality Engineer: NPD & Validation Lead
Job in
Austin, Travis County, Texas, 78716, USA
Listed on 2026-08-03
Listing for:
On-X Life Technologies, Inc.
Full Time
position Listed on 2026-08-03
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Artivion, Inc. in Austin, TX seeks a Quality Engineer to lead NPD transfers, validate processes, and ensure compliance with FDA and ISO standards. You will create and approve validation protocols, manage Design History File documentation, and drive CAPA actions.
This onsite role requires strong statistical and quality system knowledge. Minimum 4 years in a regulated medical device environment with GMP/ISO experience is expected, along with a relevant engineering or science degree.
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