• Perform detailed reviews of batch records and other quality documentation.
• Ensure all documentation aligns with established procedures and regulatory requirements.
• Approve or reject quality documents based on defined criteria and escalate discrepancies.
• Support the release process for batches, ensuring all documentation is accurate and complete.
• Collaborate with cross-functional teams to resolve documentation issues promptly.
• Handle non-conformance reports and assist with CAPA (Corrective and Preventive Actions) as required.
• Maintain strict adherence to procedures, quality standards, and compliance regulations.

• Education: Bachelor’s degree in a STEM-related field (Engineering or Science disciplines preferred).
• Experience: Minimum of 3 years in a regulated medical device or pharmaceutical manufacturing environment (internships, co-ops, or academic projects do not qualify).
• Proven experience with:
• Batch record review and approval processes.
• Quality document review in manufacturing, design, or release contexts.
• Handling non-conformances and CAPA processes (preferred).
• Skills:
• Strong attention to detail and accuracy in documentation.
• Ability to meticulously follow established procedures.
• Understanding of medical device quality documentation requirements.
• Excellent organizational and problem-solving skills.
• Other Requirements:
• Must work onsite in Austin, TX during designated hours.

1. Ability to follow and enforce procedures.
2. Strong attention to detail.
3. Comprehensive understanding of medical device quality documentation standards.

Pay Range: $30/hr. - $34/hr.