Job Description

Job Code: #10291
Date Posted: 08/28/2018
Job Location: Malden MA

Job Description:


Position overview

Develop and maintain record retention and archive process. Bring record and document control area into compliance. Identify improvement opportunities. Support quality, product development, and manufacturing department record control function. Be able to quickly learn companies EDM system to import records, perform document control reviews, and maintain QMS documentation. Must be able to review records for completion, obtain any information make necessary changes using GDPs. Handle filing of paper records, including copying, scanning, and securing signatures.

Duties and responsibilities

  • Organize and maintain hard copy, electronic, and EDMs controlled records and documents including DHF, 510K, LHRs, etc.
  • Maintenance of historical records (manual and electronic): archiving of hard copy records, managing of outside archival resources, and manage Document Control Room
  • Maintain chain of custody on requested records
  • Perform document control QC check of QMS documents
  • Maintain backups of logs and records
  • Manage change control activities
  • Supervise temps for special short-term document control projects
  • Provide assistance for document research projects
  • Assist with assembling documentation packages for regulatory agencies
  • Audit support
  • Administrative assistance to VP QA/RA


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, or to train technically-competent individuals in company specific software.

  1. High School Diploma
  2. 3-4 year of experience in Document Control, preferably in an ISO 13485 or FDA regulated environment.
  3. Knowledge of ISO 13485, FDA and MDD concepts and guidelines preferred.
  4. Must be able to work within a EDM system
  5. Understand and implement GDPs
  6. Excellent communication and organizational skills.
  7. Strong attention to detail.
  8. Strong interpersonal skills and ability to work with others in a positive and collaborative manner in office environment.
  9. Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
  10. Knowledge of various MS Office applications such as: Word, Excel, Powerpoint and Visio.
  11. Ability to handle multiple tasks in a fast paced environment and still provide accurate and complete

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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