Duties:
Join the Internal Systems and Services group as a Documentation Systems Specialist, an internal service organization within Research and Development. We empower project teams by ensuring the meticulous management and archiving of design documentation and records, adhering strictly to quality and regulatory requirements. Our responsibilities include facilitating the organized storage of project documents within electronic systems and providing crucial support to product teams for record retrieval during audits. In addition, we are committed to continuous improvement, actively seeking opportunities to modernize, enhance the effectiveness, and streamline documentation processes through digital innovation. We provide hands-on support to our internal customers in transitioning between process changes and tooling systems.
Responsibilities:
Verify that change orders submitted for processing include all essential information for accurate routing through document change workflows.
Provide comprehensive support for all documentation aspects of Product Development Process Document Approval (PDPDA) Change Order processing in accordance with approved procedures.
Coordinate and manage the appropriate reviewers and approvers, including the addition, removal, and modification of their roles within the Document Control System.
Assume a leadership role in ensuring error-free execution of changes within the systems, proactively troubleshooting error messages and addressing problem reports as they arise.
Serve as a primary point of contact for PDPDA users, offering expert guidance, training, and ongoing support for the document release and change process workflow.
Deliver comprehensive training on PDPDA processes, procedures, and workflows to all users of the Document Control System.
Guide and instruct others on initiating PDPDAs and other necessary documentation to maintain compliance with quality system documents and records.
Escalate critical issues to the manager as appropriate.
Actively participate in special projects and undertake other duties as required or assigned.
Perform additional tasks assigned by management that align with our team's scope of work.
Identify and champion opportunities for digital innovation within documentation management processes to enhance efficiency, accuracy, and compliance.
Evaluate and implement new digital tools and technologies to streamline workflows and improve user experience.
Contribute to the development and maintenance of digital documentation standards and best practices.
Knowledge, Skill and Ability:
Professional, positive customer-support mindset
Openness to learning new systems, tools, and facilitating others to help with change
Demonstrated ability to make well-informed decisions regarding configuration management to ensure documentation management effectively meets both regulatory and project requirements.
Strong ability to effectively prioritize tasks, meticulously track progress, and provide clear and concise status reports.
Excellent project management, organizational, active listening, verbal, and written communication skills are essential.
Proven ability to work independently with minimal supervision.
Capacity to effectively manage multiple tasks simultaneously and adapt positively to rapidly evolving priorities.
Possess strong analytical, troubleshooting, and customer service skills.
Rigorous attention to detail.
Ability to develop, enhance, and resolve issues within electronic document workflows.
Excellent computer skills with a strong working knowledge of EDMS/PLM or similar software.
Specific training and proficiency in PLM software are highly preferred.
Education:
Bachelor's Degree and relevant work experience.
Required:
Proven experience working with electronic documentation systems is a mandatory requirement.
Preferred:
Demonstrated working knowledge of quality systems, concepts, and guidelines (e.g., FDA QSR, ISO 13485 or equivalent) is highly preferred.
Experience within the medical device or other regulated industries is a significant advantage.
Experience in identifying and implementing digital solutions to improve documentation processes.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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Join the Internal Systems and Services group as a Documentation Systems Specialist, an internal service organization within Research and Development. We empower project teams by ensuring the meticulous management and archiving of design documentation and records, adhering strictly to quality and regulatory requirements. Our responsibilities include facilitating the organized storage of project documents within electronic systems and providing crucial support to product teams for record retrieval during audits. In addition, we are committed to continuous improvement, actively seeking opportunities to modernize, enhance the effectiveness, and streamline documentation processes through digital innovation. We provide hands-on support to our internal customers in transitioning between process changes and tooling systems.
Responsibilities:
Verify that change orders submitted for processing include all essential information for accurate routing through document change workflows.
Provide comprehensive support for all documentation aspects of Product Development Process Document Approval (PDPDA) Change Order processing in accordance with approved procedures.
Coordinate and manage the appropriate reviewers and approvers, including the addition, removal, and modification of their roles within the Document Control System.
Assume a leadership role in ensuring error-free execution of changes within the systems, proactively troubleshooting error messages and addressing problem reports as they arise.
Serve as a primary point of contact for PDPDA users, offering expert guidance, training, and ongoing support for the document release and change process workflow.
Deliver comprehensive training on PDPDA processes, procedures, and workflows to all users of the Document Control System.
Guide and instruct others on initiating PDPDAs and other necessary documentation to maintain compliance with quality system documents and records.
Escalate critical issues to the manager as appropriate.
Actively participate in special projects and undertake other duties as required or assigned.
Perform additional tasks assigned by management that align with our team's scope of work.
Identify and champion opportunities for digital innovation within documentation management processes to enhance efficiency, accuracy, and compliance.
Evaluate and implement new digital tools and technologies to streamline workflows and improve user experience.
Contribute to the development and maintenance of digital documentation standards and best practices.
Knowledge, Skill and Ability:
Professional, positive customer-support mindset
Openness to learning new systems, tools, and facilitating others to help with change
Demonstrated ability to make well-informed decisions regarding configuration management to ensure documentation management effectively meets both regulatory and project requirements.
Strong ability to effectively prioritize tasks, meticulously track progress, and provide clear and concise status reports.
Excellent project management, organizational, active listening, verbal, and written communication skills are essential.
Proven ability to work independently with minimal supervision.
Capacity to effectively manage multiple tasks simultaneously and adapt positively to rapidly evolving priorities.
Possess strong analytical, troubleshooting, and customer service skills.
Rigorous attention to detail.
Ability to develop, enhance, and resolve issues within electronic document workflows.
Excellent computer skills with a strong working knowledge of EDMS/PLM or similar software.
Specific training and proficiency in PLM software are highly preferred.
Education:
Bachelor's Degree and relevant work experience.
Required:
Proven experience working with electronic documentation systems is a mandatory requirement.
Preferred:
Demonstrated working knowledge of quality systems, concepts, and guidelines (e.g., FDA QSR, ISO 13485 or equivalent) is highly preferred.
Experience within the medical device or other regulated industries is a significant advantage.
Experience in identifying and implementing digital solutions to improve documentation processes.
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.