Quality Inspector

About the Role

This role involves maintaining quality standards through sampling, inspecting, and labeling incoming materials and components utilized in manufacturing molded parts, sub-assemblies, and finished medical devices. The inspector ensures compliance with control plans, standard operating procedures, and work instructions, while accurately documenting inspection outcomes in the Device History Records.

Key Responsibilities

• Conduct visual and dimensional receiving inspections on raw materials, packing materials, and components based on specified criteria.
• Monitor critical process inputs and variables, facilitating communication and adjustment coordination with production staff.
• Carry out in-process visual and dimensional inspections on components and packaging materials following defined standards.
• Identify and segregate nonconforming materials, properly labeling and quarantining them, and reporting these issues to supervisors.
• Participate in new product development and process validations, performing first article inspections according to drawings and using guided inspection tools and gauges.
• Inspect finished products prior to packaging, storage, and shipping to ensure adherence to specifications and customer requirements.
• Oversee maintenance and calibration of critical measuring equipment and instruments, coordinating periodic calibrations.
• Assist in root cause analyses and corrective/preventive actions for customer complaints related to quality.
• Manage quality management system (QMS) documentation and record retention.
• Document inspection results via reports, logs, and data input into quality databases.
• Maintain a safe and clean work environment in compliance with cleanroom standards and procedures.
• Contribute to the development and updating of inspection checklists and reports.
• Evaluate problems encountered and recommend initial corrective actions to supervisors.

Skills and Qualifications

• Experience in quality inspection of plastic injection molded and assembled medical devices.
• Familiarity with Quality Management Systems (QA/QC), preferably ISO 13485 standards.
• Strong mechanical aptitude, mathematical, analytical, and technical process engineering skills, particularly in troubleshooting and process improvement.
• Proficiency with computer applications such as Minitab, Microsoft Word, Excel, PowerPoint, and Outlook.

Additional Information

• The position requires standing, walking, and sitting for extended periods and willingness to work night shifts and weekends.
• All levels of employees, suppliers, and internal customers are involved in interaction according to requirements.
• The job description will be periodically reviewed and may be modified based on business needs.