Senior QS Field Action Coordinator

Johnson & Johnson•Somerville, NJ

1d•$79,000 - $127,650

About The Position

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

Requirements

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
Excellent interpersonal relations, influencing and communication skills are required.
Strong oral and written communications skills with ability to speak to broad, non‐technical audiences that are both internal and external personnel.
Skilled at preparing executive briefings and broad communications.
Advanced skills on Microsoft Office software, including PowerPoint, is required.
Ability to work in fast paced environment and rapidly shifting priorities with business acumen.
Highest ethical and integrity standard.
Prioritization of work to meet deadlines.
Able to lead and progress work forward in the face of ambiguity.
Ability to handle and resolve conflict situations and influence key business stakeholders to deliver mutually beneficial outcomes

Nice To Haves

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 multiple issues at a time.
Experience with internal/external audits, Risk Management, and recruiting/onboarding of prospective team members is preferred.
Experience leading collaborative efforts within teams and implementing continuous improvement activities is preferred.

Responsibilities

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.
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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits