Job Title: Quality Assurance Specialists

Location: Remote

Overview:

Seeking a QA Specialist to support retrospective review and remediation of Design History File (DHF) documentation. This role will ensure design control documentation meets regulatory requirements and internal quality standards through independent QA review.

Required Experience:

• 6+ years of experience in Quality Assurance within regulated industries (medical device preferred)
• Strong experience with Design Controls and DHF documentation
• Experience in remediation projects / audit readiness
• Knowledge of 21 CFR Part 820 and ISO 13485
• Experience reviewing design lifecycle documentation (User Needs, Inputs, Outputs, V&V)
• Strong skills in documentation review, traceability, and compliance assessment

Key Responsibilities:

• Perform QA review of design control documentation including User Needs, Design Inputs/Outputs, V&V, and Design Transfer
• Assess documentation for completeness, traceability, and regulatory compliance
• Identify gaps, inconsistencies, and quality risks in DHF documentation
• Provide review comments and recommendations to remediation teams
• Ensure proper documentation of QA review outcomes
• Support cross-functional teams in remediation activities