Hitachi Chemical Diagnostics, Inc.

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Document Control Specialist

Title: Document Control Specialist
Reports to: RA/QA Manager
Department: RA/QA
Status: Non-exempt

General Summary/Objective (Purpose of position)

The Document Control Specialist position is located in Mountain View, CA. This position is responsible for maintaining the sites electronic Access Databases and Document Control activities such as part number and order number assignments, revision control of documents/drawings, processing change orders, data entry and coordination in electronic databases, and paper documentation.

Essential Duties and Responsibilities

  • Maintain existing Access Databases.
  • Manage the Document control processes, including initiating process improvements, develop and maintain reports and matrices, create ad hoc reports, as requested. Ensure accuracy and integrity of data.
  • Coordinate interaction between stakeholders to resolve discrepancies and ensure appropriate changes are documented.
  • Participate in cross-functional improvement teams
  • Create Safety Data Sheets using SDS Prod software
  • Maintain all document distribution locations (i.e. satellite binders) to assure they are documented and up-to-date. File and distribute document copies in paper and electronic format.
  • Perform other duties as assigned.

Position Requirements (Knowledge, skills and abilities required to perform satisfactorily in the position)

  • Strong technical writing skills required.
  • Ability to effectively communicate in English (written and verbal) with all levels of employees
  • Ability to teach and train employees effectively.
  • Ability to work cooperatively in a team environment.
  • Strong organizational skills.
  • Self-motivated.
  • Thorough knowledge of all the PDM Database Programs: Document Control, Top/Down BOM, Serial Number tracking, Design History.
  • Experience with various software programs including file manager, access database, word processing, spreadsheets and flowcharts.
  • Advanced knowledge of Microsoft Word: Formatting, Forms, Frames, Tables, Borders, Numbering, Inserting and Bookmarks
  • Understanding of 21 CFR 820, ISO 13485 and IVD Directive

Education and Experience

  • BA Degree (preferred)
  • Minimum three (2) years recent DCO “Document Change Order” and Document Control System experience.
  • Working Knowledge of Quality System Regulations (QSR) and ISO13485 knowledge, helpful.

Supervisory Responsibility

  • This position has no supervisory responsibilities.

Work Environment

  • Professional office environment
  • This role routinely uses standard office equipment such as computers, phones and photocopiers

Physical Demands

  • Long periods of sitting, viewing computer monitor, using keyboard and mouse (continuously for up to two (2) hours at a time and up to eight (8) hours total in a day).

Position type and expected hours of work

  • Full Time

Travel Demands

  • None

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Additional Information

Affirmative action plan/equal employer opportunity (AAP/EEO) statement

Hitachi Chemical Diagnostics, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Hitachi Chemical Diagnostics, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Disclaimer

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. Hitachi management reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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