Remote Quality Specialist

Job Summary

This 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 & Coordination

• Coordinate the end‑to‑end execution of field actions, including recalls, field safety corrective actions (FSCAs), product corrections, and customer notifications
• Track field action milestones, deliverables, and closure activities to ensure timely and compliant execution
• Serve as a primary quality contact for field service, distribution, and commercial partners during active field actions

Quality Systems & Documentation

• Maintain 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 events
• Ensure alignment with J&J / corporate quality standards, procedures, and global QMS requirements

Cross‑Functional Collaboration

• Interface with Regulatory Affairs on field action strategy, reporting requirements, and health authority notifications
• Partner with Operations, Supply Chain, and Customer Service to support product return, remediation, replacement, or rework activities
• Support communication and alignment across global and regional stakeholders

Compliance & Audit Support

• Prepare documentation and evidence for FDA, ISO, and internal audits
• Support inspection readiness related to post‑market surveillance and field action processes
• Ensure all activities meet global regulatory and quality standards

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3–7+ years of experience in:
• Medical device Quality Systems
• Post‑market or Commercial Quality
• Field actions, complaints, or recalls
• Strong working knowledge of:
• FDA 21 CFR Part 820
• ISO 13485
• Post‑market surveillance and field action processes
• Experience working in regulated quality systems (eQMS)

Preferred / Plusses

• Prior experience at medical device manufacturers (Class II or III)
• Familiarity with J&J MedTech quality frameworks
• Experience supporting global field actions
• Strong project management and cross‑functional coordination skills