Dexcom Corporation is a pioneer in continuous glucose monitoring (CGM). We are seeking a QA Engineer 2 to support the start-up of our first European manufacturing site in Athenry, Ireland. As a QA Engineer, you will play an integral part in the validation and quality assurance of site equipment, utilities, and processes in compliance with Dexcom procedures.
Requirements
- Coordinate and participate in the validation and quality assurance of site equipment, utilities, and processes
- Review validation protocols and final reports to ensure they meet cGMP standards
- Manage validation investigations and implement corrective actions as needed
- Communicate regularly with peers and management regarding activities, escalating issues or concerns as necessary
- Design methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products
- Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems
- Review, update, and maintain existing quality management processes and procedures
- Initiate non-conformances/CAPAs and complete investigations as required
- Perform risk management activities (e.g., FMEA, risk assessments) to ensure the safety and effectiveness of products
- Plan, implement, and manage compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution
- Monitor and report on quality metrics, such as defect rates and process capability
Benefits
- Full and comprehensive benefits program
- Growth opportunities on a global scale
- Access to career development through in-house learning programs and/or qualified tuition reimbursement
- Exciting and innovative, industry-leading organization committed to employees, customers, and communities