Quality Assurance Engineer II

Quality Assurance Engineer II

Requirements

• Review, approve, and close all work orders by working with the Metrology and Instrumentation Department to comply with site calibration and maintenance standard operating procedures (SOPs).
• Strong proficiency in using Calibration, Maintenance, and Out Of Tolerance (OOT) management systems like BMRAM or equivalent laboratory equipment management systems.
• Support the facilities/Calibration department with daily, weekly, and monthly work orders.
• Generate and review OOT records, assess their impact, document risk assessments, and ensure timely closure to meet site and company quality metrics.
• Monitor the monthly workload for department assignments to ensure compliance with established service level agreements.
• Generate monthly quality equipment calibration and maintenance data to support the site’s Quality Management System (QMS).
• Review and approve completed records within the Life Cycle System maintenance database.
• Support site and department daily activities as a quality approver and coordinator.
• Review and support Internal and External audits for all calibration, maintenance, and OOT records to comply with ISO 13485, ISO 9001, and FDA regulations.
• Provide input to the Calibration and Equipment Maintenance Manager on developing and implementing a comprehensive quality calibration program, including instrumentation budget, adherence to department metrics, equipment service-related contracts, and equipment reliability and regulatory compliance.
• Support routine monitoring of the Equipment Life Cycle Management Program and provide input to the daily activities for the Instrumentation team.
• Develop a coordinated support strategy to support the business and balance competing priorities.
• Perform equipment and process validation studies, including writing, executing, and/or reviewing protocols, reports, data analysis, and deviations for new, existing, and site relocation activities.
• Author and execute Installation, Operational, and Performance qualifications for analytical and manufacturing equipment.
• Support facility and controlled non-classified environmental manufacturing area validation and qualification of GMP equipment and functions throughout the facility.
• Review and update FMEA or Risk documents as needed for validation activities for the site.
• Perform additional duties to ensure business continuity and support site and business needs.

Responsibilities

No responsibilities provided.

Preferred Qualifications

• Certified Quality Engineer (CQE) or equivalent certification is preferred.
• Knowledge of ISO 13485, ISO 9001, and FDA regulations is highly.