Quality Systems Specialist I

About the role

Cirtec Medical is seeking a Quality Systems Specialist I to support its Quality Management System across all sites. The role focuses on administration, coordination, and maintenance of key QMS processes, ensuring compliance with regulatory requirements for Class II and III medical devices.

Key responsibilities

• Support microbiologists by collecting, compiling, trending, analyzing, and reporting microbiological and environmental monitoring data.
• Assist investigations related to microbiological excursions, contamination events, and adverse trends.
• Maintain microbiology records in line with company procedures and regulatory standards.
• Administer controlled documents within the electronic Quality Management System, handling revisions, approvals, releases, obsolescence, and distribution.
• Coordinate archival and retrieval of quality records according to retention requirements.
• Support Engineering Change Orders (ECOs) and related document implementation activities.
• Assist Supplier Quality Engineers and Managers by maintaining supplier qualification records, compiling scorecards, tracking performance metrics, and managing corrective action requests.
• Provide support for quality metrics, training system administration, and continuous improvement initiatives.

Required profile

• Strong attention to detail and analytical abilities.
• Knowledge of regulatory requirements for medical device quality systems.
• Experience with document control and records management processes.
• Familiarity with microbiology monitoring concepts and data analysis.
• Ability to collaborate across functional teams and support continuous improvement.

Required skills

• Electronic Quality Management System (eQMS) administration
• Document control and records retention
• Microbiology data analysis and reporting
• Supplier quality management and corrective action tracking
• Quality metrics reporting and support