This role sets quality standards for in-process activities and leads testing method development, sampling, and training. Responsibilities include process evaluation, improvement suggestions, vendor management, and maintaining regulatory compliance.
Primary Responsibilities:
Develop and implement methods for process control, validation, improvement, testing, and inspection.
Design experiments to identify sources of variation and use statistical methods for analysis.
Conduct product testing and analysis to maintain quality levels and reduce defects.
Collaborate with suppliers to address quality issues and lead supplier qualifications.
Ensure corrective actions are implemented (CAPA, SCAR)
Provide Quality expertise in Product Development, Design Control, Risk Management, and CE Technical Files.
Create and maintain product documentation in compliance with regulations.
Coordinate product testing with internal and external labs.
Ensure compliance with domestic and international regulations.
Lead investigations of non-conformance and develop corrective actions.
Education:
Bachelor's degree in Engineering, Science, Math, or a related technical field.
Work Experience:
Minimum of 2 years of experience in Quality or Engineering in Medical Devices, drugs, or related fields.