Quality Engineer
actalentservices
Job Description
- Develop, implement, and maintain quality systems in alignment with FDA QSMR requirements and applicable ISO standards.
- Support design control activities throughout the product lifecycle, including risk management, verification, validation, and design transfer.
- Conduct thorough root cause analyses for quality issues using tools such as FMEA, 5-Why, and Fishbone diagrams.
- Lead and manage corrective and preventive actions (CAPA) to address nonconformances and prevent recurrence.
- Handle nonconformance events by documenting issues, coordinating investigations, and driving timely resolution.
- Collaborate with cross-functional teams to ensure quality requirements are integrated into product design and manufacturing processes.
- Apply statistical techniques to analyze quality data, monitor process performance, and identify opportunities for improvement.
- Support validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure processes and equipment consistently meet specifications.
- Maintain accurate and compliant quality records and documentation in accordance with regulatory and internal requirements.
- Contribute to continuous improvement initiatives aimed at enhancing product quality, process efficiency, and regulatory compliance.