QC Engineer

QC Engineer

Requirements

• Bachelor’s degree in Engineering (e.g., Electrical, Mechanical, Optical, Biomedical) or a related scientific discipline.
• Minimum of 5 years of experience in quality control within a manufacturing environment, preferably involving complex electro-mechanical instruments or medical devices.
• Strong understanding of quality control principles, methodologies, and tools (e.g., statistical process control (SPC), root cause analysis, failure mode and effects analysis (FMEA)).
• Experience with optical systems and their performance testing, including familiarity with optical alignment, measurement techniques, and troubleshooting.
• Knowledge of mechanical inspection techniques, including the interpretation of engineering drawings and the use of precision measuring instruments.
• Familiarity with electronic testing and troubleshooting methodologies.
• Understanding of motion control systems and their impact on overall instrument performance.
• Experience with data acquisition and analysis software for quality control purposes.
• Excellent analytical and problem-solving skills with a strong attention to detail.
• Ability to interpret technical drawings, specifications, and test procedures.
• Strong written and verbal communication skills, with the ability to clearly document findings and present data.
• Ability to work independently and collaboratively within cross-functional teams.
• Familiarity with ISO 9001 or other relevant quality management systems.
• Experience with non-conformance management and CAPA processes.
• Ability to travel international and domestically occasionally.

Responsibilities

• Develop, implement, and maintain comprehensive quality control procedures and inspection plans for analytical instruments and their sub-assemblies (optical, mechanical, electronic, and motion control systems).
• Perform incoming inspection of critical components and materials to ensure compliance with specifications and quality standards.
• Conduct in-process quality checks during assembly to identify and address any deviations or potential issues.
• Execute rigorous final testing and performance verification of completed analytical instruments, focusing on the functionality of the optical biosensor and overall system performance.
• Analyze test data using statistical methods to evaluate product quality, identify trends, and drive continuous improvement efforts.
• Document all quality control activities, inspection results, and non-conformances accurately and thoroughly.
• Investigate and troubleshoot quality issues, working collaboratively with manufacturing and engineering teams to determine root causes and implement corrective and preventive actions (CAPA).
• Participate in the development and validation of new test methods and equipment.
• Ensure compliance with relevant quality standards and regulatory requirements (e.g., ISO standards).
• Contribute to the training of manufacturing personnel on quality control procedures and best practices.
• Manage and maintain calibration records for test and measurement equipment.
• Participate in internal and external audits as required.
• Identify opportunities for process optimization and efficiency improvements within the quality control function.
• Perform other special projects and assignments as required.

Preferred Qualifications

No preferred qualifications provided.