Quality Engineer
Listed on 2026-03-13
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Engineering
Quality Engineering
Senior Quality Engineer TRB (Technical Review Board) Lead
Jacksonville, FL
Role Description s:
Roles Responsibilities
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 engineeringevaluate attributes risks and impacts related to change management. A key responsibility of TRB is preserving and maintaining the original design intent when changes are proposedensuring 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
- Ensure change meets quality and compliance expectations
Key Responsibilities 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.
Key Responsibilities 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.
Key Responsibilities 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 at risk.
- Act 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.
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