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HM's Top Needs:
Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs. Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory. Manages the change order process and prepares for change approvals by stakeholders. Prepares change management status reports. Ensures customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.
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Functional Skills: Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.
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Education Required:Â College Degree
Years’ Experience Required: 1-5 yearsÂ
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours a week.
Work Location:
Do they need to be local to any MDT office and if so where? 6743 Southpoint Drive North, Jacksonville Florida 32216
Does this person need to be on site? If so, full time or part time? Onsite preferred, Hybrid or remote will be considered as well
Responsibilities may include the following and other duties may be assigned. Processes change orders ranging from simple-to-complex for the creation and revision of product process and system designs. Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders including engineering quality manufacturing operations and regulatory. Manages the change order process and prepares for change approvals by stakeholders. Prepares change management status reports. Ensures customer requirements are implemented while maintaining compliance to applicable policies procedures regulations and standards. Functional Skills: Change Control Document Management Compliance Product Lifecycle Management Electronic Document Management Systems Enterprise Resource Planning ERP Systems. Additional Skills: Problem Solving Detail Oriented Cross-Functional Collaboration Customer Service Process Improvement Communication.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects ndash from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties. Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decision-making.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product.
Sr Config Assurance Admin
6743 Southpoint Drive North Jacksonville, FL 32216 US
Posted: 11/30/2023
2023-11-30
2024-01-04
Employment Type:
Contract
Job Category: Non-Clinical
Job Number: 592132
Is job remote?: Yes
Country: United States
Job Description
HM's Top Needs:
- Ability to understand change control process
- Ability to communicate complex and technical information in a creative and engaging way to diverse audiences, orally and in writing, in an easily-understood and actionable manner
- Familiarity with FDA Documentation requirements.
Processes change orders, ranging from simple-to-complex, for the creation and revision of product, process, and system designs. Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders, including engineering, quality, manufacturing, operations and regulatory. Manages the change order process and prepares for change approvals by stakeholders. Prepares change management status reports. Ensures customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.
Â
Functional Skills: Change Control, Document Management, Compliance, Product Lifecycle Management, Electronic Document Management Systems, Enterprise Resource Planning (ERP) Systems.
Â
Education Required:Â College Degree
Years’ Experience Required: 1-5 yearsÂ
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours a week.
Work Location:
Do they need to be local to any MDT office and if so where? 6743 Southpoint Drive North, Jacksonville Florida 32216
Does this person need to be on site? If so, full time or part time? Onsite preferred, Hybrid or remote will be considered as well
Responsibilities may include the following and other duties may be assigned. Processes change orders ranging from simple-to-complex for the creation and revision of product process and system designs. Reviews and analyzes change data provided by all functions and facilitates coordination of changes with applicable stakeholders including engineering quality manufacturing operations and regulatory. Manages the change order process and prepares for change approvals by stakeholders. Prepares change management status reports. Ensures customer requirements are implemented while maintaining compliance to applicable policies procedures regulations and standards. Functional Skills: Change Control Document Management Compliance Product Lifecycle Management Electronic Document Management Systems Enterprise Resource Planning ERP Systems. Additional Skills: Problem Solving Detail Oriented Cross-Functional Collaboration Customer Service Process Improvement Communication.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects ndash from design to implementation - while and adhering to policies using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties. Makes improvements of processes systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decision-making.
Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product.
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