Quality Applications Specialist

Mg Staffing Group

1d • Onsite

About The Position

The Quality Applications Specialist supports quality systems and product transfer activities by ensuring compliant validation of computerized systems and manufacturing processes. The role focuses on sterilization equipment, process validation, and quality system compliance in regulated environments. This position works cross-functionally with engineering, quality, IT, and operations teams to maintain compliance with federal and international regulatory requirements.

Requirements

• Minimum 3 to 6 years of relevant experience in quality, validation, or process engineering within regulated industries.
• Bachelor’s Degree in Engineering completed.
• Knowledge of sterilization machines and sterilization processes
• Process validation experience
• Statistical analysis, Process Failure Mode Analysis (pFMEA), and First Time Quality methodologies

Nice To Haves

• Experience with process validation and quality system validation
• Knowledge of sterilization technologies
• Strong understanding of risk management tools (pFMEA)
• Experience with statistical analysis tools
• Familiarity with GMP and regulatory compliance environments

Responsibilities

• Conduct validation of Quality Information Technology Systems, including preparation and execution of validation documentation.
• Develop and maintain validation protocols and documentation such as SOPs, validation plans, and reports.
• Ensure compliance with federal regulations and international quality standards governing computerized systems.
• Support product transfer activities, with emphasis on sterilization equipment and processes.
• Coordinate validation activities with clients, developers, engineering teams, and operational personnel.
• Monitor and report the status of validation activities to ensure regulatory compliance.
• Perform system administration and configuration for quality IT systems.
• Identify requirements for compliant computerized operations and implement procedures to maintain compliance.
• Maintain awareness of current regulatory requirements, audit policies, and industry best practices.
• Support quality improvement initiatives focused on First Time Quality (FTQ) and process efficiency.

What This Job Offers

• Career Level: Mid Level