Quality Systems Documentation Specialist

Job Title : Quality Systems Documentation Specialist

Location: Scarborough, Maine

Shift Timings: 8 AM to 5 PM (Monday-Friday)

Role Overview

Responsible for maintaining and supporting the electronic Quality Management System (eQMS), including document control, change management, and quality system documentation to ensure compliance with medical device regulations and internal quality standards.

Key Responsibilities

• Administer Change Control and other modules in Agile PLM within the eQMS.
• Maintain user accounts, roles, and permissions and troubleshoot system issues.
• Support implementation of new QMS modules or software.
• Manage SOPs, forms, and documentation changes through the eQMS.
• Monitor and track document review and approval workflows.
• Develop and deliver training for eQMS users.
• Support process improvements based on quality metrics and trends.
• Ensure work is completed within defined timelines and compliance requirements.

Basic Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biotechnology, Life Sciences, or related field.
• 2–5 years experience in the medical device industry, preferably in Quality Systems, Document Control, or Change Control.
• Proficiency with Microsoft Office tools.

Preferred Qualifications

• Knowledge of ISO 13485, FDA QSR, CMDR, IVDD/IVDR, and 21 CFR Part 11.
• Experience with Agile PLM or other eQMS systems.
• Strong documentation, analytical, and communication skills.
• Experience with medical device quality systems and change management.
• Strong attention to detail, organization, and ability to manage multiple priorities.