Position Details

Salary $94K – $151K USD / year

Type Full-Time

Experience senior

Exp. Years 6+ years of medical device quality engineering experience

Education Bachelor's degree in Engineering or related field

Category Engineering (Non-Software)

About this role

Staff Quality Engineer for TRB & Change Control SME for JJV. Lead TRB discussions, administer and improve global change control processes, ensure compliance with ISO and regulatory requirements, and drive continuous improvement across quality systems.

Key Responsibilities

Lead and moderate Technical Review Board meetings and document decisions
Administer and improve Global Change Control processes
Ensure compliance with ISO 13485, 21 CFR 820, ISO 14971
Partner cross-functionally to assess and mitigate risk
Track metrics and drive continuous improvement initiatives

Technical Overview

Involves TRB leadership and global change control governance within Johnson & Johnson Vision; requires deep knowledge of QMS, ISO 13485, 21 CFR 820, ISO 14971; cross-functional collaboration across engineering, RA/QA, operations, and manufacturing; focus on process metrics and improvements.

Ideal Candidate

The ideal candidate is an experienced Staff Quality Engineer with 6+ years of medical device quality engineering, strong QMS/ISO and regulatory knowledge, TRB leadership, and Change Control governance experience, capable of leading cross-functional teams across multiple sites.

Must-Have Skills

Bachelor's degree in Engineering or related field6+ years of medical device quality engineering experienceExperience with ISO 1348521 CFR 820ISO 14971Lead TRB discussionsAdminister and improve Global Change Control processesPartner cross-functionally to assess and mitigate riskTrack metrics and drive continuous improvement initiatives

Nice-to-Have Skills

Agility JumpsAnalytical ReasoningAnalytics DashboardsCoachingCollaboratingCommunicationCompliance ManagementData CompilationData QualityData SavvyDocument ManagementProblem SolvingQuality AuditingQuality Control (QC)Quality Management Systems (QMS)Quality ServicesQuality StandardsSystem AuditsSystems Analysis

Required Skills

Bachelor's degree in Engineering or related field6+ years of medical device quality engineering experienceExperience with ISO 1348521 CFR 820ISO 14971TRB leadershipQuality Management Systems (QMS)Change ManagementDesign ControlsRisk ManagementQuality AuditingProcess ImprovementDocumentation ManagementStrong communicationCollaborative leadership

Hard Skills

ISO 1348521 CFR 820ISO 14971Technical Review Board (TRB)Quality Management Systems (QMS)Change ManagementDesign ControlsRisk ManagementQuality AuditingProcess Improvement

Soft Skills

leadershipcommunicationcollaboratingproblem solvingquality mindedattention to detail

Industry & Role

Industry Healthcare & Medical

Job Function Lead TRB and change control governance to ensure quality compliance and continuous improvement for JJV's quality systems.

Role Subtype Quality Engineer

Tech Domains Quality Management Systems, Design Controls, Risk Management, QMS

Keywords for Your Resume

Staff Quality EngineerTRBTechnical Review BoardQMSQuality Management SystemsISO 1348521 CFR 820ISO 14971Change ControlDesign ControlsRisk ManagementQuality AuditingProcess ImprovementRegulatory complianceQuality SystemsCross-functional collaborationLeadershipdocumentationanimal welfareSVVC

Deal Breakers

Lack of medical device quality engineering experience, No experience with ISO 13485 / 21 CFR 820, Inability to lead cross-functional teams

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