Quality Engineer - Lead

Hi,

Job Title: Senior Quality Engineer – TRB (Technical Review Board) Lead

Location: Jacksonville, FL

Jd

Role Descriptions:

• 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- 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.
  
  

Essential 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 : - 732-860-7306| Email: veer@vrkitvision.com