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Medical Document Control Specialist

Company: Sanmina SCI
Location: Carrollton
Posted on: January 11, 2022

Job Description:

Category (For Job Seekers)
H5551 - Carrollton TX Plant - Carrollton, TX 75006 US (Primary)
Job Description
Sanmina Corporation (Nasdaq: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, computing and storage, automotive and clean technology sectors. Sanmina Corporation has facilities strategically located in key regions throughout the world.
Medical Document Control Specialist
Job Purpose:
The Document Control Specialist role has primary responsibility for supporting and managing the Document Control System, assisting with development and implementation of standard operating procedures in compliance with applicable FDA, ISO-13485, CE and other regulatory certification requirements as well as with internal policies and objectives.
Nature of Duties:

  • Responsible for supporting the execution of document control activities to ensure compliance to applicable medical device Quality Management System (QMS) policies, procedures and executed forms (e.g. design, development, production, labeling and distribution records) and associated regulations or standards (e.g. US QSR, ISO 13485, etc)
  • Support execution of control and traceability for QMS documents through maintenance of logs, databases and catalogues in compliance with applicable QMS and regulatory requirements (e.g. ISO 13485)
  • Support periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production and distribution forms and templates for compliance to QMS policies and procedures, ISO 13485, US 21CFR11, and US 21CFR820 requirements'
  • Review and maintain various documents such as drawings, manufacturing specifications and procedures to ensure compliance with all regulatory documentation standards
  • Prepares status reports, assigns, and monitors document and part numbers
  • Reviews documents for completeness and compliance with procedures
  • Maintain Design History, Risk Management and Usability Engineering Files to assure compliance to the company's procedures
  • Assists in the compilation of regulatory filing documents
  • Work with Quality Manager to support monitoring of quality processes.

    Education and Experience:

    • High School Diploma or equivalent required
    • Bachelor's Degree in a related field is an asset
    • 2 to 4 years working knowledge in Document Control or an administrative Quality role in the field of medical devices or related industry
    • Working knowledge of Document Management Systems
    • General knowledge of U.S. and international regulations including FDA, ISO, and cGMP guidance documents
    • Highly organized and detail oriented with strong follow-up skills to manage large volumes of documentation with an ability to understand priorities
    • Able to communicate clearly, orally and in writing, and exchange information accurately
    • Strong computer skills with MS Office (e.g. Word, Adobe, Visio, and Excel) and with Quality Systems (e.g. Document Management Systems, Quality Management System)
    • Experience with Agile and Oracle a plus
    • Ability to create and interpret quality summary reports
    • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing quality principles
    • Ability to perform under pressure, providing support during internal, customer, or regulatory audits

      Sanmina is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Keywords: Sanmina SCI, Carrollton , Medical Document Control Specialist, Healthcare , Carrollton, Texas

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