onsite
Quality Assurance Engineer I - Spirit Omega
QA Engineer
Quality Assurance Engineer I responsible for developing and managing the quality management system, driving process improvements, and executing product inspections, qualifications, and corrective actions using ISO standards and statistical methods.
About the role
Key Responsibilities
- Develop, maintain, and continuously improve the Quality Management System in alignment with ISO 9001 and industry best practices.
- Plan, coordinate, and execute product inspections, qualification tests, and appraisal activities across manufacturing lines.
- Perform root cause analysis on non‑conformances and lead corrective and preventive action (CAPA) initiatives.
- Apply statistical process control techniques to monitor process capability and drive data‑based improvements.
- Ensure compliance with internal quality requirements and external regulatory standards.
- Document findings, generate reports, and communicate quality expectations to cross‑functional teams.
Requirements
- Bachelor’s degree in Engineering, Quality Assurance, or a related technical field.
- 2+ years of experience in a manufacturing or production environment with a focus on quality systems.
- Hands‑on experience with ISO 9001, GMP, or similar quality frameworks.
- Proficiency in root cause analysis tools (e.g., 5 Whys, Fishbone) and statistical analysis software.
- Strong written and verbal communication skills, with the ability to influence and train team members on quality standards.