Senior Quality Engineer (TRB Lead) - Medical Device QMS

VARITE is looking for a qualified Senior Quality Engineer (TRB Lead) - Medical Device QMS for one of its clients in Jacksonville, FL (Onsite).WHAT THE CLIENT DOES? The company started out as a hardware/software vendor, but over time added more subscription-based services. WHAT WE DO? Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services. HERE'S WHAT YOU'LL DO:Job Details: Senior Quality Engineer (TRB Lead) - Medical Device QMS Jacksonville, FL (Onsite) Contract Position Pay Rate Range: $ 71.42 - 73.52/hr. Req ID: 10564360Role 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: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. If this opportunity interests you, please respond by clicking on EasyApply. Know someone who would be perfect for this role? Refer them to us and if they are hired, you could be eligible for our employee referral bonus! Help us grow our team with top talent from your network. VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status

Created: 2026-03-04