Senior QS Field Action Coordinator

4 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Quality

Quality Systems

Professional

• Cincinnati, Ohio, United States of America
• Cornelia, Georgia, United States of America
• San Angelo, Texas, United States of America
• Somerville, New Jersey, United States of America

Johnson & Johnson is currently recruiting for Senior QS Field Action Coordinator! This position can be located at any US J&J Medtech site, with a preference for Somerville, NJ or Cincinnati, OH.

This position will have responsibility for planning, implementing, execution, standardizing, coordinating, and managing Field Actions (FA) for Ethicon.

• Responsible for all Field Actions activities as Recall Coordinator – to coordinate recall strategy plan definition with business stakeholders, coordinate periodic recall meetings with the Field Action team, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of all activities and follow up recall activities to successful completion per established recall strategy.
• Responsible for participating and providing field action inputs to the Quality Review Board for decision in containment/corrections to be implemented in the field.
• Responsible for reporting field actions metrics to appropriate review boards such as management review, CAPA review board, periodic metrics reporting, etc.
• Manage, maintain, and improve and standardize Field Action process to ensure compliance with FDA regulations, ISO Standards and all applicable regulatory authority requirements.
• Support data requests for post market surveillance, regulatory registrations, etc, as well as provide data for periodic reports, presentations, and metrics related to product risk escalations as needed.
• Support internal and external audits in preparation activities and serve as a subject matter expert during audits.
• Implement/modify quality systems to address changing regulations or industry standard, providing regulatory interpretation and guidance where required.
• Other responsibilities include but are not limited to: coordinate and participate in special projects as assigned; act as backup support for product escalation Quality Engineers or other product Field Action teams.
• Actively participate in audit and compliance review processes.
• Demonstrate customer support and maintaining knowledge of Ethicon products and services.
• Identify, lead and/or support appropriate projects towards desired business outcomes.
• Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.
• Support all needed quality system and business related requests for data analysis, QSMR, BPDR, QRB, DRB, CAPA, NC, etc.
• Responsible for ensuring personal and company compliance with all federal, state, local and company regulations, policies, and procedures.
• Perform other duties assigned as needed.

A minimum of a Bachelors or equivalent University degree is required.

• 4-6 years relevant work experience is required
• Experience facilitating meetings with stakeholders from multiple functions
• Experience in the medical device, pharmaceutical or other highly regulated industry preferred.
• Knowledge of ISO and/or cGMP regulations is preferred.
• Experience in an FDA regulated environment is an asset.
• Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment is preferred.
• Work in a fast‑paced environment and prioritize…