Quality Engineer - Lead

VRK IT Vision Inc.; Jacksonville (FL); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading medical device company based in Jacksonville is seeking a Senior Quality Engineer to lead the Technical Review Board (TRB) efforts. In this role, you will ensure compliance with medical device regulations and lead discussions around change management. Responsibilities include leading TRB meetings, ensuring quality and compliance in documentation, and collaborating with cross-functional teams. The ideal candidate will have a strong understanding of ISO 13485 and experience in quality assurance within the medical device space.

Qualifications

• Experience leading TRB and managing change management processes in a medical device environment.
• In-depth knowledge of ISO 13485 and 21 CFR 820 regulations.
• Strong communication skills for cross-functional collaboration.

Responsibilities

• Lead and document TRB meetings with cross-functional stakeholders.
• Review and ensure compliance with change management documentation.
• Collaborate with SMEs and communicate quality expectations.

Skills

Medical Device Regulations

Risk Management

Quality Compliance

Cross-Functional Collaboration

Job description

Hi,

Senior Quality Engineer – TRB (Technical Review Board) Lead

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, and 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.
• 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 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: [e-mail]