Johnson & Johnson MedTech · 23 hours ago
Senior QS Field Action Coordinator
Cincinnati, OH
Full-time
Onsite
Mid, Senior Level
$79K/yr - $128K/yr
4+ years expJohnson & Johnson is a leader in healthcare innovation, and they are seeking a Senior QS Field Action Coordinator. This role is responsible for planning, implementing, and managing Field Actions for Ethicon, ensuring compliance with regulations and standards.
Hospital & Health Care
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
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
Qualification
Required
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
Preferred
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
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
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)).
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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