Job Title: Manager, Documentation Services

The following represents some of the main responsibilities of the above position. This list is not in any order of importance and should not be considered an exhaustive list of possible duties of the position. NxStage Medical, Inc. maintains the right to modify this list at any time.

Summary

Lead and Manage all Quality System functions related to product life cycle documentation, controlled procedures, and site document control. Responsible for the overall management of the controlled documentation system including the assessment, maintenance and improvement of associated quality systems. Manage day-to-day activities that result in the, creation, maintenance, change control, and archival/retrieval of, product documentation and documentation that comprises the Device Master Record, Design History File, and Device History Record. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Specific Duties:

• Develop and implement strategies for document and data management including electronic media and hardcopy necessary to support global business plans and objectives.
• Manage the documentation control functions throughout documentation lifecycles including but not limited to:
• Generation and control of document change orders,
• Document formatting and processing,
• Routing, tracking and facilitating timely documentation review, approval, and implementation
• Distribution of documents in a controlled manner to ensure that only the most recent versions are available for use and that they are available as needed.
• Maintaining control over hard copy documents within the QA files.
• Maintaining control of library of standards and regulations
• Maintaining performance metrics for the Documentation Control System and performs analysis of document processing measures.
• Training and assistance for employees and other groups on the use of electronic document control system and good documentation practices. Supports training activities such as Quality Systems and New Hire Orientation.
• Perform Administrator role for the Agile PLM database for document control and other quality system processes which include design/development issue tracking, customer complaints, CAPA, and NCMR. This position is considered the resident expert in the Agile PLM database. Responsibilities include but are not limited to:
• Establishing and configuring collaborative workflows to ensure efficiency in quality processes
• Establishing and implementing roles and privileges
• Configuring user definable text fields, list boxes, multi-lists, etc.
• Configuring reports and global searches
• Ensuring changes to system are validated in accordance with requirements
• Oversee maintenance of company electronic employee training record database which includes configuration of database fields, configuring training curriculums, adding/deleting users, preparing and distributing reports on training compliance, etc.
• Oversee maintenance of company equipment calibration program, coordinating calibration activities with R&D, Operations, and outside calibration services. Maintain Equipment (EQ) files as appropriate.
• Maintain company record retention program including establishing policies for record retention, coordinating archiving of records, timely retrieval, and disposable of obsolete records per policy
• Identify, research, and implement opportunities for process improvement that are supportive of department and corporate vision/objectives.
• Facilitates others' participation in the continuous improvement program; investigates and solves basic problems that impact work processes within a unit or department.
• Support audit activities.

Requirements:

• Bachelor's Degree and minimum of 2 years managing the documentation control function within a regulated environment. Experience in the Medical Device or similarly regulated industry required.
• Experience in managing the entire product life cycle documentation process including validation, developmental and product release.
• Demonstrated experience in the accurate, timely, and compliant control of documentation.
• Strong proofreading and editing skills and experience in good documentation practices.
• Experience with Agile PLM software application or a similar document control application required.
• Ability to read and understand technical documents.
• Experience in selecting, implementing and maintaining documentation management systems required.
• Experience in training coordination, supervision, and/or project management a plus.
• Must be detail oriented and have strong verbal, written, communication and organizational skills.
• Dynamic interpersonal and teamwork skills to effectively interact with customers at all levels.
• High proficiency in Microsoft Word. Proficiency in Excel and other databases, document management, presentation, diagramming and project tracking software.

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