QC Engineer

ESSENTIAL DUTIES AND 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. 

QUALIFICATIONS

• 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.  

PHYSICAL REQUIREMENTS

• To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
• This role will require lengthy periods of standing and sitting. 
•  Ability to lift, push, pull, carry, and/or move up to 50lbs. 
• The employee will be required to use hands for computer work. 
• Health screening:  
• Travel: