QA Technician III

Job Description

Job Description

We are seeking a highly skilled and experienced Quality Assurance Technician (Level 3) specializing in Metrology to join our team in the medical plastic injection molding industry. In this role, you will play a critical role in ensuring the precision and accuracy of our medical device components through advanced metrology techniques and equipment.

Responsibilities :

• Metrology Expertise : Utilize advanced metrology equipment and techniques to conduct precise measurements and analysis of medical plastic injection molded components, ensuring compliance with tight tolerances and specifications.
• Calibration : Perform calibration and maintenance of metrology equipment, including coordinate measuring machines (CMM), optical comparators, surface roughness testers, and other precision measurement tools, to ensure accuracy and reliability of measurements.
• Inspection Planning : Develop inspection plans and methodologies for complex medical device components, collaborating with engineering and production teams to establish appropriate measurement techniques and tolerances.
• Statistical Analysis : Apply statistical analysis methods, such as statistical process control (SPC) and capability studies, to assess the capability of manufacturing processes and identify opportunities for improvement.
• Root Cause Analysis : Lead investigations into non-conformities and deviations from quality standards, utilizing root cause analysis methodologies to identify underlying causes and implement corrective actions.
• Documentation : Maintain detailed records of metrology activities, inspection results, and calibration records in accordance with regulatory requirements and quality management system (QMS) procedures.
• Training and Mentoring : Provide training and mentorship to junior technicians and production personnel on metrology techniques, equipment operation, and quality assurance principles.
• Compliance : Ensure compliance with relevant regulatory standards and guidelines, including FDA regulations and ISO requirements, by following established metrology procedures and protocols.
• Continuous Improvement : Drive continuous improvement initiatives related to metrology processes, equipment, and methodologies, aiming to enhance efficiency, accuracy, and overall quality within the manufacturing environment.
• Communication : Collaborate effectively with cross-functional teams, including engineering, quality assurance, and production, to communicate metrology-related findings, address quality issues, and drive resolution of problems.

Requirements :