Job Title: Quality Engineer

The Quality Engineer will play a critical role in overseeing product launches and the daily management of processes, products, and equipment. This position involves comprehensive involvement from initial stages to completion, including supplier quality, internal quality, process development, and documentation changes that support manufacturing, quality audits, and preparation for third-party audits.

• Develop and implement all quality-related processes and documentation for new program development and current sustainment business.
• Engage directly in manufacturing process development and continuous improvement to meet or exceed quality metrics and process metrics for current and new business.
• Review, analyze, and resolve customer, internal, and supplier quality issues through root cause analysis and implementation of corrective actions.
• Develop and implement preventative actions and continuous improvements within manufacturing and quality areas.
• Control the non-conformance area including inventory, disposition, and associated costs.
• Manage and review gage equipment, certifications, and calibrations, including programming CMM or other coordinate measurement equipment.
• Ensure the calibration log is complete and up-to-date.
• Coordinate with the quality inspector for daily inspection, measurement, testing, and approval of all components, products, and processes using quality metrics to ensure targets are met.
• Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
• Utilize quality management system software and SPC systems daily.
• Participate in conducting supplier and internal system and process audits.

• Bachelor's Degree in Engineering.
• 3+ years' experience working in quality within medical device industry (can be OEM or contract manufacturer).
• Experience working with ISO13485 standards.
• Process capability experience related to processes, production, equipment, and assembly.
• Product development experience.
• Strong problem-solving methodology, including systematic approaches like 5Y, Fishbone, and 8D.
• Proficiency in quality statistics, metrology, biomedical technologies, auditing, Six Sigma, machining, fabrication, and assembly.

The facility is located in Kalamazoo and operates as a satellite operation with a total of 50-60 employees. The Quality Team comprises 2 quality technicians and quality inspectors, along with 2 Quality Engineers. Minimal travel is required, up to 5% within the US and Canada. Work hours range from 40-45 hours per week.