More jobs:
Quality Engineer - Lead
Job in
Jacksonville, Duval County, Florida, 32290, USA
Listed on 2026-05-25
Listing for:
VRK IT Vision Inc.
Full Time
position Listed on 2026-05-25
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Hi,
Senior Quality Engineer – TRB (Technical Review Board) Lead
Jacksonville, FL
Jd
Role Description s:- TRB (Technical Review Board) Role Expectations Scope The TRB is a cross‑functional review forum where representatives from Technical community, Life sciences, Product engineering, Process engineering, Software systems engineering, Product design, Regulatory affairs, Quality assurance, Quality engineering evaluate attributes, risks, and impacts related to change management.
- A key responsibility of TRB is preserving and maintaining the original design intent when changes are proposed ensuring safety, performance, regulatory compliance, and product quality are not compromised.
- The selected candidate will interact with all SMEs, lead and navigate complex discussions, identify gaps, risks, and missing information, drive alignment and decision‑making, and ensure change meets quality and compliance expectations.
- TRB Leadership – lead, moderate, and document TRB meetings with cross‑functional stakeholders. Drive structured, objective technical and quality discussions. Evaluate design intent, risks, usability, and regulatory implications. Facilitate decision‑making and ensure ownership of actions and risks.
- Quality Compliance – apply deep understanding of Medical Device QMS (ISO 13485, 21 CFR 820). Review documentation associated with change management (ECOs, design updates, deviations, CAPAs). Lead and review risk assessments per ISO 14971. Ensure compliance with design control and technical documentation requirements.
- Cross‑Functional Collaboration – engage SMEs across technical, engineering, RAQA, and manufacturing teams. Explain required changes and clarify expectations. Communicate assertively, push back, and say no when quality or compliance is as primary bridge between change owners and review teams.
- Process Improvement – evaluate and improve TRB and change management workflows. Identify gaps, bottlenecks, and inefficiencies. Drive continuous improvement initiatives.
Skills:
Senior Quality Engineer TRB (Technical Review Board) Lead
Skills:EIS:
Medical Device & Regulations; EIS: MDD Risk Management
Thanks & Regards
Veer. T | VRKIT Vision Inc
Contact: | Email:
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