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Medical Device File Compliance Coordinator

FTS Inc
Kennebunk, ME Full Time
POSTED ON 1/30/2025
AVAILABLE BEFORE 3/29/2025

Medical Device File Compliance Coordinator

Schedule: Monday – Friday, 8:00 AM – 4:30 PM (100% Onsite)

Must-Have Qualifications:

  • Proficiency in Microsoft Office and Excel
  • Ability to follow written procedures
  • Strong attention to detail
  • Ability to work independently

Position Overview:

This role is responsible for the development, maintenance, and management of Medical Device Files (MDFs) in accordance with ISO 13485 standards. The position also involves performing change controls, updating quality management procedures, managing records, and conducting internal audits to ensure compliance with the Quality Management System.

Key Responsibilities:

  • Develop, review, maintain, and update medical device files in compliance with ISO 13485.
  • Collaborate with various departments (development, operations, engineering, and quality) to collect and properly document necessary records.
  • Address and resolve non-compliance issues related to MDFs.
  • Initiate change controls and document change requests to update procedures and processes.
  • Support or lead continuous improvement initiatives for quality management system processes.
  • Perform other related duties as needed.

Minimum Qualifications:

  • Associate or bachelor’s degree in life sciences, engineering, or a related field.
  • 3 years of experience in a manufacturing environment preferred.

Skills & Experience:

  • Comprehensive knowledge of ISO 13485 and other relevant regulations and standards.
  • Previous experience in creating and managing Medical Device Files.
  • Strong attention to detail and accuracy.
  • Excellent documentation and record-keeping skills.
  • Strong communication and interpersonal abilities.
  • Ability to work cross-functionally and lead teams.
  • Proficiency in document management systems.
  • Internal auditing experience preferred.
  • Project management skills preferred.

Job Types: Full-time, Contract

Pay: $40.33 - $45.33 per hour

Benefits:

  • Health insurance
  • Paid time off
  • Referral program
  • Vision insurance

Schedule:

  • 8 hour shift
  • Monday to Friday

Ability to Commute:

  • Kennebunk, ME 04043 (Required)

Work Location: In person

Salary : $40 - $45

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