Demo

Document Management Specialist

Indotronix Avani Group
Kennebunk, ME Full Time
POSTED ON 2/3/2025
AVAILABLE BEFORE 5/2/2025

Role : Document Control Analyst – Medical Devices

Location : Kennebunk, ME

Pay Rate : $30 / hr. on W2 all incl

Duration : 10 to 12 Months

Responsible for administration of quality management system documents and records required for Client Life Sciences processes. Responsible for initiation of document changes, distributions, notifications and fulfilling internal and external document distribution.

Must haves :

Proficiency in Microsoft Office and Excel

Ability to follow written procedures

Detail oriented

Ability to work autonomously

Description of Work :

  • Generates, reviews, and maintains quality system documents including procedures, work instructions, job aids, certificate of conformances, etc. in compliance with ISO 13485, ISO 9001, and 21 CFR 820 standards.
  • Initiates Change Controls and Document Change Requests to update procedures and processes.
  • Works within departments and with various departments to update processes and procedures.
  • Assists in managing the document review and retention processes.

Supports or leads continuous improvement initiatives for document control related processes.

  • Supports other Quality Assurance functions as needed (internal audit, CAPAs, etc.)
  • Other duties as required

    Minimum Qualifications :

    2 years related experience required. Associate or bachelor’s degree in life sciences, engineering, or a related field preferred. Prior experience in a manufacturing environment is preferred

    Salary : $30

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