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Document Control Specialist - Ventura, United States - Quest Staffing Services Inc
Description
Job DescriptionJob Description
Primary Function:
Coordinates documentation activities through change management. Follows established procedures and policies to meet the demands of document control in a regulated medical device company.
Duties/Responsibilities:
Regulatory
Responsible for overall coordination of Document Control function within the company.
Coordinates change control activities.
Supports user requests for documentation.
Supports change management of labeling, specifications, artwork, manufacturing procedures, etc.
Supports Quality System training and maintains training records.
Maintains training effectiveness program.
Responsible for coordinating engineering change orders (ECO), facilitates review, approval, and retention of documentation.
Supports QA department with completing scheduled Internal Audits.
Serve as global administrator of electronic Quality Management System, QT9.
Maintain laboratory notebooks and log sheet.
Assign unique identification numbers to documents, parts, and components in accordance with established protocols.
Other duties as deemed necessary by supervisor.
Special Knowledge/Skills:
Proven experience in document control, preferably in a fast-paced environment.
Proficient in communication and working with teams that consist of diverse personnel and scattered locations.
Advanced English skills:
writing, grammar, proofreading, redlining.
Advanced computer skills:
data entry/typing, Word, Excel, Visio, Flowcharts, other Microsoft Office software.
Technical experience and knowledge in developing and coordinating documentation systems.
Full understanding of documentation control systems within a medical device company certified to ISO Standards and FDA QSR
Proactively identify opportunities for process enhancements and efficiency improvements within the document control function.
Exceptional organizational skills and attention to detail, with the ability to manage multiple tasks concurrently.
Experience:
Proven success in working with and improving medical device quality systems.
Knowledge of both FDA QSR and ISO standards.
Demonstrated abilities and knowledge in document change management.
Education/Training:
Prefer Bachelor of Science or equivalent with 3-5 years' experience in documentation control systems, with preference in coordination and administration of systems within a FDA QSR/ISO.