What are the responsibilities and job description for the Staff Change Management Specialist position at J&J Family of Companies?
Staff Change Management Specialist
**Description**
Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Change Management Specialist to be located in Irvine, CA, Warsaw, IN, Westchester, PA, Palm Beach Gardens, FL or Cincinnati, OH. Other MedTech sites may be considered.
At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.
Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.
Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.
OVERALL RESPONSIBILITIES:
Execute and lead Change Management activities on the MedTech Product Lifecycle Management (PLM) program. Activities include serving as a Change Control and Document Management subject matter expert for MedTech PLM Deployments and PLM functionality development exercises.
POSITION DUTIES & RESPONSIBILITIES:
Responsible for serving as a Change Control and Document Management Subject Matter Expert (SME), while ensuring compliance with applicable standards and regulations.
Represent the MedTech PLM team while working with internal clients and application administration to ensure business needs are met in a compliant manner.
Aid in design and development Change Control & Document Management processes utilizing Windchill functionality and CM2 (configuration management) methodology.
Resolve issues and provide guidance to businesses with regard to PLM Document and Change Management processes.
Test new PLM functionality as developers create the features for future business use.
Serve as Windchill PLM SME for the deployment of MedTech Operating companies.
Assist in the development of Document Management and Change Control configurations/changes to configurations.
Help define the local processes and how they will be executed.
Support Organizational Change Management and Data Migration activities, including testing of configurations.
Support CAPA, Non-Conformance and Audit Observation activities as needed.
Support all audits and inspections (internal and external) as requested, as well as Legal inquiries and holds.
Other duties as assigned by management.
**Qualifications**
EDUCATION & EXPERIENCE REQUIREMENTS:
Minimum of a bachelor's degree is required.
Masters degree preferred.
Minimum 5 years business experience, including 3 years' experience with Quality Systems and/or Change Control in a regulated industry is required.
A preferred minimum of 2 years of people management experience and the ability to set tactical direction to support strategic initiatives is required.
Extensive change control experience within Product Lifecycle Management systems is required - Windchill, ADAPTIV, and/or Agile e6 experience highly preferred.
Experience CMII Change Management Methodology is preferred.
Intimate knowledge of Change Management practices, including regulatory body requirements.
Experience with authoring and maintaining procedures and work instructions is preferred.
Ability to apply Project Management/ Process Excellence skills to obtain necessary results is preferred.
Strong team-building skills, with the ability to function as a team player or leader on cross-functional teams to obtain necessary results is required.
Strong time management skills, including the ability to multi-task and prioritize work in a dynamic environment is required.
The anticipated base pay range for this position is: 88,000 to 142,600
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
**Primary Location** NA-US-California-Irvine
**Other Locations** NA-US-Florida-Palm Beach Gardens, NA-United States, NA-US-Pennsylvania-West Chester, NA-US-Ohio-Cincinnati, NA-US-Indiana-Warsaw
**Organization** Biosense Webster Inc. (6010)
**Job Function** Quality Systems
**Req ID:**
-
W2206097706
**Description**
Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Change Management Specialist to be located in Irvine, CA, Warsaw, IN, Westchester, PA, Palm Beach Gardens, FL or Cincinnati, OH. Other MedTech sites may be considered.
At Biosense Webster, Inc. we have one goal - to ensure those with cardiac arrhythmias can live the lives they want. This means transforming the latest advancements in electrophysiology into a suite of tools that empowers physicians with a range of treatments for the best outcomes.
Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools. And through onsite training, online courses and our global education centers, we work together to set new standards every day.
Learn more about Biosense Webster at www.biosensewebster.com and follow us on LinkedIn.
OVERALL RESPONSIBILITIES:
Execute and lead Change Management activities on the MedTech Product Lifecycle Management (PLM) program. Activities include serving as a Change Control and Document Management subject matter expert for MedTech PLM Deployments and PLM functionality development exercises.
POSITION DUTIES & RESPONSIBILITIES:
Responsible for serving as a Change Control and Document Management Subject Matter Expert (SME), while ensuring compliance with applicable standards and regulations.
Represent the MedTech PLM team while working with internal clients and application administration to ensure business needs are met in a compliant manner.
Aid in design and development Change Control & Document Management processes utilizing Windchill functionality and CM2 (configuration management) methodology.
Resolve issues and provide guidance to businesses with regard to PLM Document and Change Management processes.
Test new PLM functionality as developers create the features for future business use.
Serve as Windchill PLM SME for the deployment of MedTech Operating companies.
Assist in the development of Document Management and Change Control configurations/changes to configurations.
Help define the local processes and how they will be executed.
Support Organizational Change Management and Data Migration activities, including testing of configurations.
Support CAPA, Non-Conformance and Audit Observation activities as needed.
Support all audits and inspections (internal and external) as requested, as well as Legal inquiries and holds.
Other duties as assigned by management.
**Qualifications**
EDUCATION & EXPERIENCE REQUIREMENTS:
Minimum of a bachelor's degree is required.
Masters degree preferred.
Minimum 5 years business experience, including 3 years' experience with Quality Systems and/or Change Control in a regulated industry is required.
A preferred minimum of 2 years of people management experience and the ability to set tactical direction to support strategic initiatives is required.
Extensive change control experience within Product Lifecycle Management systems is required - Windchill, ADAPTIV, and/or Agile e6 experience highly preferred.
Experience CMII Change Management Methodology is preferred.
Intimate knowledge of Change Management practices, including regulatory body requirements.
Experience with authoring and maintaining procedures and work instructions is preferred.
Ability to apply Project Management/ Process Excellence skills to obtain necessary results is preferred.
Strong team-building skills, with the ability to function as a team player or leader on cross-functional teams to obtain necessary results is required.
Strong time management skills, including the ability to multi-task and prioritize work in a dynamic environment is required.
The anticipated base pay range for this position is: 88,000 to 142,600
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
**Primary Location** NA-US-California-Irvine
**Other Locations** NA-US-Florida-Palm Beach Gardens, NA-United States, NA-US-Pennsylvania-West Chester, NA-US-Ohio-Cincinnati, NA-US-Indiana-Warsaw
**Organization** Biosense Webster Inc. (6010)
**Job Function** Quality Systems
**Req ID:**
2206097706
W
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