coordinator administration

About the Role

As a QRA Coordinator, Product Field Actions, you will oversee and support field action execution activities from initiation through completion. You will work closely with quality, regulatory, engineering, operations, and customer-facing teams to ensure field actions are executed accurately, documented properly, and completed in compliance with applicable regulations and company procedures.

Key Responsibilities

• Coordinate Product Field Action (PFA) and recall execution activities.
• Maintain execution plans, tracking tools, status reports, and supporting documentation.
• Ensure field action activities comply with regulatory requirements, quality system procedures, and internal policies.
• Support preparation and submission of notifications and status updates to regulatory agencies.
• Communicate with customers, business partners, internal stakeholders, and management regarding field action progress.
• Collaborate with engineers, technicians, process leads, and execution owners to ensure timely completion of action items.
• Monitor timelines, risks, deliverables, and escalation points related to ongoing recalls and field actions.
• Develop and maintain training materials and procedural documentation related to field action processes.
• Support internal and external audits associated with Product Field Actions.
• Provide regular reporting and updates to leadership regarding execution status and completion metrics.
• Support interactions with international partners involved in global field action activities.
• Perform additional regulatory and quality coordination activities as needed.

Required Qualifications & Skills

• High School Diploma plus 2 years of relevant experience (Associate's or Bachelor's degree preferred).
• Experience coordinating regulated activities and maintaining compliance-related records and documentation.
• Experience managing timelines, priorities, deliverables, and execution tracking.
• Strong project coordination and stakeholder management skills.
• Excellent written and verbal communication skills.
• Experience creating reports, maintaining records, and documenting activities accurately.
• Ability to collaborate effectively with cross-functional teams and external stakeholders.
• Proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities simultaneously.
• Ability to work with customers and stakeholders in challenging or sensitive situations.

Preferred Qualifications

• Product Field Action (PFA) or Recall Coordination experience.
• Regulatory Affairs or Quality Assurance experience.
• Medical Device industry experience.
• Experience within FDA-regulated or other highly regulated industries.
• Prior Project Management experience.
• Experience supporting audits and regulatory inspections.
• Experience working with TrackWise, SharePoint, and/or Visio.
• Exposure to global regulatory processes and international stakeholder coordination.