Senior Quality Assurance Engineer
hace 5 días
Transforming Healthcare through Quality Excellence
Baxter Healthcare is a leading medical innovation company that has been pioneering significant medical advancements for over 85 years. Our mission is to improve healthcare outcomes for millions of patients worldwide.
We are seeking a highly skilled Senior Quality Assurance Engineer to join our team. As a key member of our quality team, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our products and services.
Key Responsibilities:
- Regulatory Compliance: Ensure compliance with QSR regulations part 820, ISO-13485, and other applicable regulations.
- Quality Performance Metrics: Ensure and report metrics to monitor quality performance.
- Non-Conforming Material Process: Ensure that the process of non-conforming material is executed according to established procedures, complying with determined metrics.
- Work Instructions and Validation: Support the creation, maintenance, and improvement of work instructions, as well as validation activities, IQs, TMVs, OQs, and PQs for designated areas.
- Non-Conformance, Corrective Action, and Preventive Action (NCR, SNCR, CAPA): Lead or participate in NCR, SNCR, CAPA activities in accordance with established procedures, ensuring compliance with quality objectives.
- Statistical Control Techniques: Assist department management and staff in the implementation of statistical control techniques to improve efficiency and operational effectiveness.
- Data Analysis: Responsible for the analysis of data obtained from the field to investigate and solve problems identified through Post Market Surveillance reports.
- Project Transfers and Value Stream Projects: Participate in project transfers through the identification and correction of gaps identified in manufacturing processes, establishing product acceptance criteria, ensuring quality controls, and supporting compliance with project deadlines.
Requirements:
- 3 to 5 years of quality experience.
- Advanced level of English.
- Bachelor's degree in Industrial Engineering or related field.
- Training/Knowledge on risk management ISO 14971 and ISO 13485.
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