Engineer I, QA
Core
Entry-level QA Engineer ensuring product quality, regulatory compliance, and customer complaint resolution in a GMP environment for life science products.
Role type
Junior IC Quality Assurance Engineer
Builds
Quality compliant products and systems for global customers
Domain
Life Sciences / Medical Devices / Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
complaint log management, Trackwise system usage, failure analysis, product qualification review, change order review, deviation analysis, pFMEA review, COA/COC issuance, ISO/cGMP regulatory compliance, NPI project support
Preferred skills
pharmaceutical/medical device/life science industry experience, Mechanical or Electronics Engineering background, Quality Systems or GMP certifications, knowledge of ISO 13485/9001 and FDA regulations
Technologies
Trackwise System, Microsoft Office
Responsibilities
Retrieve and process customer complaints from databases; Lead resolution of quality issues on the manufacturing floor; Perform failure analysis on product failures; Review test protocols and reports for product qualification; Establish Device Master Record Index (DMRI); Review change orders, deviations, and pFMEA; Provide Certificates of Analysis and Conformance; Support New Product Introduction and Transfer projects; Ensure compliance with ISO and FDA regulations.
Seniority
Junior, entry-level IC
