Terumo Medical Corporation
Document Control Specialist
Terumo Medical Corporation, Elkton, Maryland, us, 21922
Job SummaryThis Document Center - Document Control associate is the expert in maintaining control of all quality documentation. The associate follows the established procedures and policies needed to meet the demands of document control in a regulated medical device company.This position works independently, with minimal supervision, in accomplishing daily tasks and is responsible for working with subject matter experts to organize, maintain, and update controlled documents. This position trains others to use document control processes and document management system software. This associate works closely with all departments to maintain a compliant program. All functions of the Document Control Specialist must comply with quality system good manufacturing practices and other applicable regulations.Job Details/ResponsibilitiesDocument Management:
Maintain and oversee all quality documentation to ensure accuracy, completeness, and compliance with established procedures and policies.Process Adherence:
Follow and enforce document control procedures in alignment with quality system good manufacturing practices and other applicable regulations.Independent Operation:
Accomplish daily tasks with minimal supervision, demonstrating a high degree of self-management and accountability.Collaboration:
Work closely with all departments to ensure a compliant document control program is maintained.Training:
Educate and train team members and other employees on document control processes and the use of the document management system software.Updating Documentation:
Regularly update and organize controlled documents in collaboration with subject matter experts.Other : Performs other job-related duties as assigned.This position is integral to maintaining a compliant and efficient document control program, ensuring that all documentation meets the highest standards of quality and regulatory compliance.Following all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.Position Requirements:Knowledge, Skills, and Abilities (KSAs) Proven experience in document control within a regulated environment, preferably in a medical device company.Strong problem-solving skills and the ability to adapt to changing requirements.Ability to critically think to solve problems.Effective interpersonal skills for working with various departments and stakeholders.Detail-oriented with a focus on accuracy and compliance.Ability to clearly communicate, both verbal and written with all levels of organization.Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents.Ability to work independently with minimal supervision.Proficiency in document management system software.Strong computer knowledge (MS Office) and technical writing skills.Must have demonstrated initiative and ability to handle multiple tasks.Good theoretical knowledge with ISO standards (ISO 13485) regulatory requirements, and related labeling regulations (21 CFR 820).Background Experience Requires
an associate degree,4-year degree preferred.3 years of experience in a manufacturing environment required.Experience in a document control environment preferred.Experience in training and mentoring others in document control processes.Experience working in the medical or other highly regulated industry, specifically ISO 13485 and FDA CFR820.
Maintain and oversee all quality documentation to ensure accuracy, completeness, and compliance with established procedures and policies.Process Adherence:
Follow and enforce document control procedures in alignment with quality system good manufacturing practices and other applicable regulations.Independent Operation:
Accomplish daily tasks with minimal supervision, demonstrating a high degree of self-management and accountability.Collaboration:
Work closely with all departments to ensure a compliant document control program is maintained.Training:
Educate and train team members and other employees on document control processes and the use of the document management system software.Updating Documentation:
Regularly update and organize controlled documents in collaboration with subject matter experts.Other : Performs other job-related duties as assigned.This position is integral to maintaining a compliant and efficient document control program, ensuring that all documentation meets the highest standards of quality and regulatory compliance.Following all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.Position Requirements:Knowledge, Skills, and Abilities (KSAs) Proven experience in document control within a regulated environment, preferably in a medical device company.Strong problem-solving skills and the ability to adapt to changing requirements.Ability to critically think to solve problems.Effective interpersonal skills for working with various departments and stakeholders.Detail-oriented with a focus on accuracy and compliance.Ability to clearly communicate, both verbal and written with all levels of organization.Must have strong proofreading skills and organizational skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents.Ability to work independently with minimal supervision.Proficiency in document management system software.Strong computer knowledge (MS Office) and technical writing skills.Must have demonstrated initiative and ability to handle multiple tasks.Good theoretical knowledge with ISO standards (ISO 13485) regulatory requirements, and related labeling regulations (21 CFR 820).Background Experience Requires
an associate degree,4-year degree preferred.3 years of experience in a manufacturing environment required.Experience in a document control environment preferred.Experience in training and mentoring others in document control processes.Experience working in the medical or other highly regulated industry, specifically ISO 13485 and FDA CFR820.