Quality Engineer - DMR Remediation & Transfer

Overview:

We are seeking a contract Quality Engineer to support Design Master Record (DMR) remediation and transfer activities as part of the closure of a site. This role will focus on documentation remediation and ensuring quality system compliance during a critical transition period. The ideal candidate is an early-career Quality Engineer or Design Quality Engineer (QE/DQE) with strong attention to detail and experience working within regulated environments.

Key Responsibilities:

• Support DMR remediation activities, including reviewing, updating, and organizing documentation to ensure completeness and compliance
• Assist with documentation transfer activities related to site closure
• Identify gaps in existing documentation and drive remediation efforts
• Collaborate cross-functionally with engineering, quality, and operations teams
• Ensure all documentation aligns with internal quality systems and regulatory requirements
• Maintain accurate records and provide updates on remediation progress

Qualifications:

• Bachelor’s degree in Engineering or a related technical field
• 1–4 years of experience in Quality Engineering or Design Quality within a regulated industry (medical device preferred)
• Familiarity with Design Master Records (DMR) and documentation control processes
• Strong organizational skills and high attention to detail
• Ability to work independently in a fast-paced, deadline-driven environment
• Effective communication and collaboration skills

Preferred Qualifications:

• Experience supporting remediation or site transfer/closure activities
• Knowledge of FDA regulations and/or ISO 13485

Terms

• 4+ month contract
• Remote