Description

You will provide quality guidance for product and process sterility, supporting sterilization operations and sterility assurance programs.

Responsibilities

• Support product sterility assurance and compliance across multiple manufacturing sites.
• Execute validation activities including master validation planning, protocol development, and IQ/OQ/PQ support.
• Lead investigations for product and process discrepancies, including CAPA and customer complaints.
• Manage product changes impacting sterilization equipment and associated laboratory testing.
• Maintain compliance with FDA and ISO standards through annual product reviews, environmental controls, and bioburden testing.
• Perform internal audits to ensure quality system compliance.

Required Skills

• 2+ years of experience in a highly regulated industry, such as medical device or pharmaceutical.
• Bachelor's degree in Science or Engineering.
• Experience with Quality Engineering principles.
• Knowledge of statistical problem-solving techniques.
• Ability to compile test data and write technical summary reports.
• Experience with change controls and electronic document management systems.
• Familiarity with FMEAs and control plans.

Preferred Skills

• Direct experience in sterility assurance or product sterilization.

Key Skills

Education

Bachelor's degree