Quality Lab Analyst

Flex

10d

About The Position

To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Quality Lab Analyst located in Austin, TX. Reporting to the Quality Manager, the Quality Lab Analyst role will support medical device process confirmation testing in a FDA 21 CFR Part 820 & ISO 9001 regulated laboratory. This role is hands-on and focused on laboratory testing, data integrity, and documentation, ensuring accurate and timely support for product release.

Requirements

Bachelor’s degree in Chemistry or related field.
2+ years of laboratory experience, preferably in medical or regulated environments.
Strong attention to detail and experience with lab documentation systems (electronic and paper-based documentation systems)
Comfortable working with small volumes, precise measurements, and lab equipment.

Responsibilities

Perform routine and non-routine laboratory testing following approved SOPs and protocols.
Prepare buffers, solutions, and test materials for PCT activities.
Execute customer-defined test designs and accurately record lab results.
Generate and maintain electronic and paper-based lab documentation in compliance with GDP.
Operate laboratory equipment (precision balances, small volumes, vacuum systems, YSI).
Support lab investigations (OOS/OOT), CAPAs, and audit readiness.
Maintain lab readiness, inventory control, 5S, and GMP conditions.
Collaborate with cross-functional teams and support continuous improvement initiatives.
Adhere to EHS and Safety-First standards.