QA Specialist II / Quality Assurance Analyst II // QA Technician II

Select Source International - Austin, TX

Full-time - Mid Level

Austin, TX

Professional, Scientific, and Technical Services

About the position

The QA Specialist II position is responsible for supporting third-party medical device operations, focusing on documentation and quality assurance processes. The role involves reviewing batch records and quality documents to ensure compliance with regulatory standards in a medical device or pharmaceutical environment. The position requires strong attention to detail and adherence to established procedures.

Responsibilities

• Support third-party medical device operations by handling batch records and device history records.
• Conduct thorough reviews of quality documents and batch releases.
• Ensure compliance with regulatory standards in documentation processes.
• Escalate issues related to documentation requirements when necessary.

Requirements

• Bachelor's degree in a STEM field (Engineering or Science preferred).
• Minimum of 3 years of experience in a medical device or pharmaceutical regulated environment, preferably in manufacturing.
• Experience with heavy documentation roles, including batch review and quality document approvals.
• Strong attention to detail and ability to follow procedures.

Nice-to-haves

• Experience with non-conformances and CAPA (Corrective and Preventive Actions).

Benefits

• 12-month contract with possible extension or conversion.