We are currently looking for experienced Quality Assurance Specialists to support Design History File (DHF) remediation and retrospective review activities in a regulated environment.

🔍 Key Responsibilities:

✔️ Perform QA review of design control documentation including:

• User Needs

• Design Inputs & Outputs

• Verification & Validation (V&V)

• Design Transfer documentation

✔️ Ensure documentation is complete, traceable, and compliant with regulatory standards

✔️ Identify gaps, inconsistencies, and potential quality risks

✔️ Provide actionable feedback to remediation teams

✔️ Document QA review outcomes effectively

✔️ Collaborate with cross-functional teams on remediation efforts

🎯 Required Qualifications:

• Experience in Quality Assurance (Medical Device industry preferred)

• Strong understanding of Design Controls and DHF documentation

• Experience with remediation projects in regulated environments

• Solid document review and compliance assessment skills