Johnson & Johnson MedTech
Overview
Senior QS Field Action Coordinator - Johnson & Johnson MedTech. This position can be located at any US J&J Medtech site, with a preference for Somerville, NJ or Cincinnati, OH.
Job Function Quality - Quality Systems.
Job Category Professional.
Locations Cincinnati, OH; Cornelia, GA; San Angelo, TX; Somerville, NJ (United States).
Position Summary This role is responsible for planning, implementing, executing, standardizing, coordinating, and managing Field Actions (FA) for Ethicon.
Key Responsibilities
Responsible for all Field Actions activities as Recall Coordinator – 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.
Participate and provide field action inputs to the Quality Review Board for decisions in containment/corrections to be implemented in the field.
Report field actions metrics to appropriate review boards such as management review, CAPA review board, periodic metrics reporting.
Manage, maintain, 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, and 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 standards, 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 maintain 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, and 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.
Ensure personal and company compliance with all federal, state, local and company regulations, policies and procedures.
Perform other duties assigned as needed.
Experience and Education Minimum: Bachelor's degree or equivalent university degree.
Required/Preferred Skills & Capabilities
4-6 years relevant work experience.
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 preferred.
Experience in an FDA regulated environment is an asset.
Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment 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 preferred.
Experience leading collaborative efforts within teams and implementing continuous improvement activities preferred.
Excellent interpersonal relations, influencing and communication skills required.
Strong oral and written communication 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, 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.
Salary Base pay range: $79,000.00 – $127,650.00.
Benefits Eligible for time-off benefits including vacation (120 hours per calendar year), sick time (40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents), holiday pay and 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 birth/adoption/foster care), bereavement leave (240 hours), caregiver leave (80 hours in a 52-week rolling period), volunteer leave (32 hours per calendar year), military spouse time-off (80 hours per calendar year).
Additional benefits available – see
employee benefits page .
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via
https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr
Job Function Quality - Quality Systems.
Job Category Professional.
Locations Cincinnati, OH; Cornelia, GA; San Angelo, TX; Somerville, NJ (United States).
Position Summary This role is responsible for planning, implementing, executing, standardizing, coordinating, and managing Field Actions (FA) for Ethicon.
Key Responsibilities
Responsible for all Field Actions activities as Recall Coordinator – 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.
Participate and provide field action inputs to the Quality Review Board for decisions in containment/corrections to be implemented in the field.
Report field actions metrics to appropriate review boards such as management review, CAPA review board, periodic metrics reporting.
Manage, maintain, 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, and 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 standards, 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 maintain 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, and 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.
Ensure personal and company compliance with all federal, state, local and company regulations, policies and procedures.
Perform other duties assigned as needed.
Experience and Education Minimum: Bachelor's degree or equivalent university degree.
Required/Preferred Skills & Capabilities
4-6 years relevant work experience.
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 preferred.
Experience in an FDA regulated environment is an asset.
Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment 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 preferred.
Experience leading collaborative efforts within teams and implementing continuous improvement activities preferred.
Excellent interpersonal relations, influencing and communication skills required.
Strong oral and written communication 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, 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.
Salary Base pay range: $79,000.00 – $127,650.00.
Benefits Eligible for time-off benefits including vacation (120 hours per calendar year), sick time (40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents), holiday pay and 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 birth/adoption/foster care), bereavement leave (240 hours), caregiver leave (80 hours in a 52-week rolling period), volunteer leave (32 hours per calendar year), military spouse time-off (80 hours per calendar year).
Additional benefits available – see
employee benefits page .
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via
https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.
#J-18808-Ljbffr