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Co od Vás očekáváme:
The Document Control Specialist will compile and maintain control records, quality documents and files related to the release of medical device software, drawings, components and documents for a cross functional set of groups including engineering, manufacturing, quality and purchasing. The Document Control Specialist is responsible for the creation and release of Engineering Change Orders (ECO’s), Deviations and maintenance of the training process.
ESSENTIAL FUNCTIONS:
Work with ECO originators to complete ECO packages and Deviations in Arena PLM
Follow NDS documented standard operating procedures
Manage and monitor training quality system elements as needed
Maintain effective change and version control of all documents, components and device items
Write and update documentation and processes as needed
REQUIREMENTS:
Minimum 1 year Document Control Specialist experience (Arena PLM highly desired/Agile PLM acceptable)
Direct experience in Medical Device Quality Systems preferred
Experience with a variety of software programs (particularly MS Excel, MS Word and Adobe Acrobat)
Ability to analyze complex information and summarize into a concise, easy to read text for reviewers
Excellent interpersonal skills, communication and organizational skills particularly across multiple levels of management
Ability to speak and write English fluently
Excellent typing skills (>50 words per minute)
Strong customer service skills and time management
Detail oriented and accurate
