Quality Engineer II Remote

Kelly Services • Mechanicsville, VA

439d • $122,720 - $122,720 • Remote

About The Position

The Quality Engineer II position at Kelly Services focuses on providing technical expertise in terminal sterilization of medical products. This role involves coordinating and executing validation activities for sterilization methods, ensuring compliance with quality systems and sterilization standards, and providing support for product design and changes. The position is remote and requires collaboration with cross-functional teams to develop sterilization requirements and lead validation processes.

Requirements

• Minimum of 5 years of experience in terminal sterilization activities in a medical device environment.
• Extensive knowledge of various modes for terminal sterilization and regulatory requirements.
• Knowledge of design quality and microbiology as it relates to sterilization and validation.
• Minimum of a Bachelor's degree in Microbiology, Engineering, Sciences or similar.

Nice To Haves

• Experience with ISO Sterilization Standards and Medical device GMPs.
• Knowledge of Lean Six Sigma concepts.

Responsibilities

• Coordinate, develop, and execute validation activities for terminal sterilization methods.
• Provide sterilization sciences expertise and validation subject matter expertise in support of product design and changes.
• Perform audits of external service contractors and laboratories.
• Ensure compliance with quality system and sterilization standards requirements.
• Lead the terminal sterilization validation requirements for new materials and products.
• Develop sterilization validation protocols and sterility assurance assessments.
• Direct activities necessary for required revalidations of validated sterilization processes.
• Actively participate in internal and external audits of manufacturing facilities and suppliers.
• Implement Root Cause Analysis concepts to investigate sterilization failures.

Benefits

• Medical, dental, and vision insurance
• Telemedicine services
• Term life and whole life insurance
• Accident insurance
• Critical illness insurance
• Legal plan
• Short-term disability
• Retirement savings plan
• Service bonus and holiday pay plans
• Transit spending account
• Paid sick leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Administrative and Support Services
• Education Level: Bachelor's degree
• Number of Employees: 10,001+ employees