QA Specialist – Design Controls Remediation
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Job Description
Role: QA Specialist Design Controls Remediation -3 OpeningsLocation: Remote (Preference for EST candidates) Duration: 9 Months (Can extend upto 24 Months)
Role Summary
QA Specialists will support the retrospective review and remediation of Design History File (DHF) documentation. Resources will provide independent QA review to ensure design documentation meets applicable regulatory requirements and internal quality system expectations.
Responsibilities
Perform QA review of design control documentation including:
User Needs
Design Inputs
Design Outputs
Design Verification and Validation (V&V)
Design Transfer documentation
Assess documentation for completeness, traceability, and compliance with applicable regulatory
requirements and internal procedures.
Identify documentation gaps, inconsistencies, and quality risks.
Provide review comments and recommendations to remediation teams.
Ensure appropriate documentation of QA review outcomes.
Support cross-functional remediation workstreams as needed.
Qualifications
Experience in Quality Assurance within regulated industries (medical device preferred).
Experience supporting or participating in remediation initiatives within regulated environments.
Familiarity with design controls and DHF documentation.
Experience reviewing design documentation in one or more phases of the design lifecycle.
Strong document review and compliance assessment skills.
Note
The QA Center of Excellence will consist of a diverse team with experience across different phases of design controls. Expertise across all phases is not required. Specific expertise in Capital Equipment, SaMD, and Manufacturing QA will be preferred.
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
