The Mom Project is excited to partner with Karl Storz Endoskope in their search for a Document Management Specialist (DMS) . This role is onsite at Karl Storz Endoskope's Stafford, TX office.
Since its beginnings in 1945, the KARL STORZ family company has grown into a global manufacturer and distributor of endoscopes, medical instruments, and devices. We are no giant on an international scale but a leader in the things that matter: creativity, flexibility, and expertise.
Our range of endoscopic instruments for human medicine, veterinary medicine, and industrial endoscopy now includes more than 15,000 products. The most recent KARL STORZ developments are in digital documentation systems and comprehensive operating room concepts. As a system supplier, the company combines its expertise in endoscopy with software solutions to achieve integration in the operating room and to support clinical process and resource management.
Reasonable accommodation may be made to enable individuals with protected disabilities to perform the essential functions of this job.
I. Job Purpose and Core Tasks
The Document Management Specialist supports KSEA-OR1 as an integral member of the Quality Management. Team driving continuous compliance and applicable regulatory requirements while ensuring OR1 products are safe and processes are optimized to support global alignment. This team member is specifically responsible for establishing, maintaining, and improving an effective Documentation and Records Controls Program for KSEA-OR1 aligned with global efforts for KARL STORZ in compliance with Quality Management System (QMS) regulations.
In the oversight of the operation of the document management system, the DMS leads the administration of all QMS documentation ensuring:
Documents are effectively created, implemented, controlled, maintained, stored, archived, protected and retrievable;
Highest levels of accuracy through process documentation and training
Highest levels of compliance with applicable standards
Highest levels of customer satisfaction
The DMS will be responsible for the training of all KSEA-OR1 personnel via the Learning Management System (LMS)
The DMS will lead continuous improvement initiatives collaborating cross-functionally to optimize user learning experience utilizing the latest technology to leverage digitization opportunities
Quality Documentation:
This position is responsible for technical writing and formatting of documents necessary to ensure compliance with ISO and FDA/QSR regulations as well as global standards for the KARL STORZ organization
This person is the responsible contact during internal and external QMS audits of ISO/FDA elements that relate to the control of documents and data, as needed
Be a liaison between KSEA-OR1 and KST for controlled documents and data activities for the implementation of global processes (as part of HQMS or other projects, as directed)
Develop and configure document management system features, such as user interfaces, access profiles, document workflow procedures, and designing templates for documents
Assisting employees with understanding the document management system, creating or revising documents, and accessing documents through local or global document management systems
Controlling the flow of documents in and out of the department while ensuring the timely completion of document management system activities
Review documents for accuracy and compliance
Analyze, interpret, or disseminate document management system performance data, including system effectiveness, efficiency, and as applicable, recommendations for improvement
Administer document management system access rights and revision control to ensure the security of the system and the integrity of all documents and records
Communicates and consult with appropriate stakeholders when assessing, acquiring, deploying new, or changing existing electronic document management systems to ensure a smooth transition and minimal disruption
Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues
Establishes and implements policies and procedures regarding document storage, sharing, transmission, and destruction
Performs other related duties as assigned
Change Management:
The DDS Specialist will lead all administration of change requests (CRF or ECM)
This position will also align and implement the utilization of global tools accordingly
Verify the gathering of data, documents, records, and forms and coordinate the processing through the document control approval processes
Reviewing and coordinating the SOP receipt approvals for notification on KS global processes
Support continuous improvement and lean process development
Support the utilization of technology to improve an organization's efficiency and profitability by reducing waste
Learning Management System:
Establish, maintain, and continually improve role-specific KSEA-OR1 Learning Curricula and end-user experience through state-of-art training materials
Reporting of training verification records on a recurring basis in support of compliance audits
Working with cross-functional leadership to review training curricula on an annual basis and adjust as needed
II. Minimum Knowledge, Education, and Skill Requirements
Minimum years of relevant work experience:
At least 5 years of related experience is required
Minimum education, certifications, and/or credentials:
Associate Degree in a related field is required
Minimum hard skill requirements (including computer and application proficiency):
Strong computer skills
Microsoft Office applications (Visio, PowerPoint, Excel, and Word), SharePoint, and SAP
Minimum soft skill requirements:
Basic understanding of laws and regulations regarding document management
Must be able to work cooperatively with others in a team-oriented environment while being responsive to changing priorities
Displays professional demeanor with a high focus on quality and compliance
Excellent interpersonal, verbal, and written communication skills cross-functionally
Detail oriented with strong organizational skills and information management capabilities
Ability to closely monitor and communicate progress on daily tasks and responsibilities to management
Excellent analytical, technical, and creative problem-solving skills
Preferred education, certifications, and/or credentials:
Bachelor's degree and at least 3 years of experience in a document control environment
Experience or exposure to good manufacturing practices, quality system regulations, and/or ISO standards is a plus
Preferred hard skill requirements:
Experience with Learning Management Systems preferred
Benefits
Medical & Vision
Dental
Short and Long Term Disability
Employee Assistance Program
Flexible Spending Account: Healthcare and Dependent Care
Voluntary Benefit
401K + Match
Wellness Program
Tuition Reimbursement
Charitable Giving Corporate Match
Vacation/Sick/Paid Holidays*
Working Advantage- Employee Discounts
Nationwide Pet Insurance
Milkstork (for traveling mothers)
InfoArmor Identity Theft Protection
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
Since its beginnings in 1945, the KARL STORZ family company has grown into a global manufacturer and distributor of endoscopes, medical instruments, and devices. We are no giant on an international scale but a leader in the things that matter: creativity, flexibility, and expertise.
Our range of endoscopic instruments for human medicine, veterinary medicine, and industrial endoscopy now includes more than 15,000 products. The most recent KARL STORZ developments are in digital documentation systems and comprehensive operating room concepts. As a system supplier, the company combines its expertise in endoscopy with software solutions to achieve integration in the operating room and to support clinical process and resource management.
Reasonable accommodation may be made to enable individuals with protected disabilities to perform the essential functions of this job.
I. Job Purpose and Core Tasks
The Document Management Specialist supports KSEA-OR1 as an integral member of the Quality Management. Team driving continuous compliance and applicable regulatory requirements while ensuring OR1 products are safe and processes are optimized to support global alignment. This team member is specifically responsible for establishing, maintaining, and improving an effective Documentation and Records Controls Program for KSEA-OR1 aligned with global efforts for KARL STORZ in compliance with Quality Management System (QMS) regulations.
In the oversight of the operation of the document management system, the DMS leads the administration of all QMS documentation ensuring:
Documents are effectively created, implemented, controlled, maintained, stored, archived, protected and retrievable;
Highest levels of accuracy through process documentation and training
Highest levels of compliance with applicable standards
Highest levels of customer satisfaction
The DMS will be responsible for the training of all KSEA-OR1 personnel via the Learning Management System (LMS)
The DMS will lead continuous improvement initiatives collaborating cross-functionally to optimize user learning experience utilizing the latest technology to leverage digitization opportunities
Quality Documentation:
This position is responsible for technical writing and formatting of documents necessary to ensure compliance with ISO and FDA/QSR regulations as well as global standards for the KARL STORZ organization
This person is the responsible contact during internal and external QMS audits of ISO/FDA elements that relate to the control of documents and data, as needed
Be a liaison between KSEA-OR1 and KST for controlled documents and data activities for the implementation of global processes (as part of HQMS or other projects, as directed)
Develop and configure document management system features, such as user interfaces, access profiles, document workflow procedures, and designing templates for documents
Assisting employees with understanding the document management system, creating or revising documents, and accessing documents through local or global document management systems
Controlling the flow of documents in and out of the department while ensuring the timely completion of document management system activities
Review documents for accuracy and compliance
Analyze, interpret, or disseminate document management system performance data, including system effectiveness, efficiency, and as applicable, recommendations for improvement
Administer document management system access rights and revision control to ensure the security of the system and the integrity of all documents and records
Communicates and consult with appropriate stakeholders when assessing, acquiring, deploying new, or changing existing electronic document management systems to ensure a smooth transition and minimal disruption
Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues
Establishes and implements policies and procedures regarding document storage, sharing, transmission, and destruction
Performs other related duties as assigned
Change Management:
The DDS Specialist will lead all administration of change requests (CRF or ECM)
This position will also align and implement the utilization of global tools accordingly
Verify the gathering of data, documents, records, and forms and coordinate the processing through the document control approval processes
Reviewing and coordinating the SOP receipt approvals for notification on KS global processes
Support continuous improvement and lean process development
Support the utilization of technology to improve an organization's efficiency and profitability by reducing waste
Learning Management System:
Establish, maintain, and continually improve role-specific KSEA-OR1 Learning Curricula and end-user experience through state-of-art training materials
Reporting of training verification records on a recurring basis in support of compliance audits
Working with cross-functional leadership to review training curricula on an annual basis and adjust as needed
II. Minimum Knowledge, Education, and Skill Requirements
Minimum years of relevant work experience:
At least 5 years of related experience is required
Minimum education, certifications, and/or credentials:
Associate Degree in a related field is required
Minimum hard skill requirements (including computer and application proficiency):
Strong computer skills
Microsoft Office applications (Visio, PowerPoint, Excel, and Word), SharePoint, and SAP
Minimum soft skill requirements:
Basic understanding of laws and regulations regarding document management
Must be able to work cooperatively with others in a team-oriented environment while being responsive to changing priorities
Displays professional demeanor with a high focus on quality and compliance
Excellent interpersonal, verbal, and written communication skills cross-functionally
Detail oriented with strong organizational skills and information management capabilities
Ability to closely monitor and communicate progress on daily tasks and responsibilities to management
Excellent analytical, technical, and creative problem-solving skills
Preferred education, certifications, and/or credentials:
Bachelor's degree and at least 3 years of experience in a document control environment
Experience or exposure to good manufacturing practices, quality system regulations, and/or ISO standards is a plus
Preferred hard skill requirements:
Experience with Learning Management Systems preferred
Benefits
Medical & Vision
Dental
Short and Long Term Disability
Employee Assistance Program
Flexible Spending Account: Healthcare and Dependent Care
Voluntary Benefit
401K + Match
Wellness Program
Tuition Reimbursement
Charitable Giving Corporate Match
Vacation/Sick/Paid Holidays*
Working Advantage- Employee Discounts
Nationwide Pet Insurance
Milkstork (for traveling mothers)
InfoArmor Identity Theft Protection
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.