Quality Design Assurance Specialist - Remote

Overview

The Quality Design Assurance Specialist will perform detailed review, remediation, and creation of Design History Files (DHFs) to ensure compliance with FDA, ISO 13485, and internal design control requirements. This role is hands-on and execution-focused, responsible for completing structured gap assessments, and generating compliant design control records for both legacy and current products.

In Short

• Temporary, Full-time Remote Position for 9 months - 1 year
• Perform comprehensive reviews of existing DHFs.
• Identify gaps, inconsistencies, and missing documentation.
• Execute remediation activities to bring DHFs into full compliance.
• Collaborate with Quality, Manufacturing, Procurement, and Regulatory teams.
• Create new DHFs or major DHF sections for products lacking complete design documentation.
• Support design control activities for product changes, sustaining work, and new product introductions.
• Ensure all documentation is inspection-ready and aligned with current regulatory expectations.
• Support internal training on design control requirements and best practices.
• Adhere to current Good Manufacturing Practices (cGMP).

Requirements

• Bachelor's degree in a technical, scientific, or related field.
• Four years of experience in medical device design controls or design assurance.
• Strong design control knowledge with experience reviewing, remediating, or creating DHFs.
• Knowledge of ISO 9001, ISO 13485:2016, and FDA QMSR.
• Proven ability to translate complex technical concepts into clear documentation.
• Strong analytical mindset and experience in root-cause analysis.

Benefits

• Opportunity to work in a remote environment.
• Hands-on experience with quality assurance in medical devices.
• Collaboration with cross-functional teams.
• Professional development and training opportunities.