Senior Documentation Control Specialist (closed)· Boston, MA
Senior Documentation Control Specialist (closed)
Boston, MA
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Job Description
Senior Documentation Control Specialist
(Greater Boston MA Area)
Position Requirements:
This position provides for the creation and development of technical documentation as well as the management and control of a corporate Quality documentation system, including the documents, records and associated processes. Works with technical teams to establish criteria and best practices for document development and management.
This position provides for the creation and development of technical documentation as well as the management and control of a corporate Quality documentation system, including the documents, records and associated processes. Works with technical teams to establish criteria and best practices for document development and management.
The Document Control Specialist will:
•Establish and maintain a central repository, including history files, for all controlled Quality & Regulatory documents and records. Perform various duties essential to the implementation and maintenance of a regulated documentation system, including coordinating efforts for the control of new and updated Quality System procedures for ISO/QSR.
• Ensure the consistency and quality of company product, process, and policy documentation.
• Assist technical team in the creation of documentation standards, such as protocols, reports, procedures, material and assembly specifications, customer documentation, and product labeling.
• Ensure the consistency and quality of documents with the change control process.
• Interface with other department staff to answer questions regarding SOPs and documentation.
• Maintain controlled documents in strict compliance to corporate policies, regulations and standards.
• Identify, generate and publish metrics and reports related to the creation and control of quality system documentation.
• Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.
• May support process training for document creation and document control processes.
• Establishes and maintains library of product and process-related reference standards, regulations, guidances, clinical articles and journals.
Requirements:
• Ensure the consistency and quality of company product, process, and policy documentation.
• Assist technical team in the creation of documentation standards, such as protocols, reports, procedures, material and assembly specifications, customer documentation, and product labeling.
• Ensure the consistency and quality of documents with the change control process.
• Interface with other department staff to answer questions regarding SOPs and documentation.
• Maintain controlled documents in strict compliance to corporate policies, regulations and standards.
• Identify, generate and publish metrics and reports related to the creation and control of quality system documentation.
• Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.
• May support process training for document creation and document control processes.
• Establishes and maintains library of product and process-related reference standards, regulations, guidances, clinical articles and journals.
Requirements:
Associates or Bachelor's Degree with 5 to 8 years of experience working with quality system documentation and product Device Master Records in a medical device design/manufacturer environment.
Knowledge of documentation systems, specifically new product development (protocols, reports, software, validation data, Design History Files), quality system (procedures, forms, quality records), and manufacturing (Bills of Material, routers, procedures, Device History Records) documentation
Experience with electronic documentation systems such as Agile, Documentum, MasterControl preferred
