Senior Quality Engineer TRB (Technical Review Board) Lead

• Posted 4 hours ago • Updated 4 hours ago

Full Time

Part Time

Fitment

Dice Job Match Score™

🛠️ Calibrating flux capacitors...

Job Details

Skills

JD
Life Sciences
Product Engineering
Process Engineering
Systems Engineering
Product Design
Regulatory Affairs
Quality Assurance
Leadership
Usability
Decision-making
QMS
ISO 13485
Documentation
Risk Assessment
ISO 9000
Design Controls
Technical Writing
Collaboration
Manufacturing
Regulatory Compliance
Process Improvement
Change Management
Workflow
Continuous Improvement
Medical Devices
EIS
Risk Management
SANS

Summary

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

Location: Jacksonville, FL

JD:

Role Descriptions: Roles ResponsibilitiesTRB (Technical Review Board) Role Expectations ScopeThe 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 expectationsKey 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

Desirable Skills:

Keyword:

Skills: EIS : Medical Device & Regulations~EIS : MDD Risk Management

Experience Required: 6-8

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10374872
Position Id: OOJ - 8380-28706-1772200167
Posted 4 hours ago

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Senior Quality Engineer TRB (Technical Review Board) Lead

Dice Job Match Score™

Job Details

Skills

Summary

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