More jobs:
Quality Engineer - Lead
Job in
Jacksonville, Duval County, Florida, 32290, USA
Listed on 2026-03-05
Listing for:
VRK IT Vision Inc.
Full Time
position Listed on 2026-03-05
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Job Title: Senior Quality Engineer – TRB (Technical Review Board) Lead
Location: Jacksonville, FL
Role OverviewThe TRB is a cross‑functional review forum where representatives from the technical community, life sciences, product engineering, process engineering, software systems engineering, product design, regulatory affairs, quality assurance, and 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.
Key Responsibilities- 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.
- 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.
- Engage SMEs across technical, engineering, RA/QA, and manufacturing teams.
- Explain required changes and clarify expectations.
- Communicate assertively, push back, and say no when quality or compliance is at risk.
- Act as primary bridge between change owners and review teams.
- Evaluate and improve TRB and change‑management workflows.
- Identify gaps, bottlenecks, and inefficiencies.
- Drive continuous improvement initiatives.
Senior Quality Engineer – TRB (Technical Review Board) Lead
- EIS:
Medical Device & Regulations, EIS: MDD Risk Management
Contact: 732‑860‑7306 |
Email:
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