Staff Scientist, MQSA

As a Staff Scientist, MQSA, you will lead technical validation and qualification programs for medical devices, ensuring compliance with global regulatory standards. This role involves developing validation strategies, executing studies, analyzing data, and collaborating with cross-functional teams to support product development and manufacturing quality.

• Lead validation strategy development, protocol authoring, and execution
• Perform reusable medical device processing, sterilization, and cleaning validations
• Conduct manufacturing residual and analytical evaluations
• Oversee equipment qualification (IQ/OQ/PQ) and temperature mapping studies
• Ensure compliance with global regulatory requirements and industry standards
• Collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs