Remote Quality Specialist

Job SummaryThis individual will support the execution and coordination of field actions and post‑market quality activities for commercially released medical devices. The role partners closely with Quality Systems, Regulatory Affairs, Operations, Field Service, and Commercial teams to ensure field actions (including recalls, corrections, and notifications) are planned, executed, documented, and closed in compliance with FDA, ISO 13485, and internal quality system requirements.Key Responsibilities:Field Action Execution & CoordinationCoordinate the end‑to‑end execution of field actions, including recalls, field safety corrective actions (FSCAs), product corrections, and customer notificationsTrack field action milestones, deliverables, and closure activities to ensure timely and compliant executionServe as a primary quality contact for field service, distribution, and commercial partners during active field actionsQuality Systems & DocumentationMaintain accurate and audit‑ready documentation within eQMS systems (field action records, change records, CAPAs, investigations)Support root cause investigations and corrective actions associated with field eventsEnsure alignment with J&J / corporate quality standards, procedures, and global QMS requirementsCross‑Functional CollaborationInterface with Regulatory Affairs on field action strategy, reporting requirements, and health authority notificationsPartner with Operations, Supply Chain, and Customer Service to support product return, remediation, replacement, or rework activitiesSupport communication and alignment across global and regional stakeholdersCompliance & Audit SupportPrepare documentation and evidence for FDA, ISO, and internal auditsSupport inspection readiness related to post‑market surveillance and field action processesEnsure all activities meet global regulatory and quality standardsRequired QualificationsBachelor’s degree in Engineering, Life Sciences, or related field3–7+ years of experience in:Medical device Quality SystemsPost‑market or Commercial QualityField actions, complaints, or recallsStrong working knowledge of:FDA 21 CFR Part 820ISO 13485Post‑market surveillance and field action processesExperience working in regulated quality systems (eQMS)Preferred / PlussesPrior experience at medical device manufacturers (Class II or III)Familiarity with J&J MedTech quality frameworksExperience supporting global field actionsStrong project management and cross‑functional coordination skills