Senior Quality Assurance Engineer
Listed on 2026-07-28
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Quality Assurance - QA/QC
Quality Engineering
Opportunity to build a company's quality management system for the next stage of growth, including added product capability, building for scale and distributing the product globally.
About Agile Search's client:
A growth-stage medical technology company recently engaged with strategic partner and positioned for expansion.
Agile Search is conducting interviews for a Senior Quality Systems Engineer to join a commercial stage company and help them build out their Quality Management System for the next growth chapter.
Role specifics:
Reporting to the organization's VP QA RA
Assume ownership of the QMS end to end, ISO 13485 and FDA QMSR; perform gap analysis for the company's growth, contribute directly to building the system, leading meetings as required, conducting risk management, making recommendations, voice of quality leading implementations.
Lead internal audits and CAPA through to root cause, build the quality metrics and statistical methods that drive risk-based decisions.
Own supplier qualification and audits, post-market surveillance and MDR reporting.
Contribute to directly shaping the quality culture for this expanding, multidisciplinary team.
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