Quality Assurance Specialist

QA Specialists(SaMD)

Remote

9 months Contract(possibility for extension up to 24 months)

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.