Katalyst Healthcares and Life Sciences
Quality Engineer
Katalyst Healthcares and Life Sciences, Elkhart, Indiana, United States, 46516
Responsibilities:
Develop, implement, and maintain quality systems to ensure compliance with industry standards and customer requirements. Collaborate with engineering and production teams to establish and monitor quality control processes. Support new product introductions by developing inspection plans, test protocols, and validation activities. Perform root cause analysis and lead corrective and preventive action (CAPA) initiatives. Conduct audits of processes, products, and suppliers to verify adherence to quality standards. nalyse data, track metrics, and generate reports to drive continuous improvement. Train and support production staff in quality standards, documentation, and best practices. Partner with supply chain and operations to ensure incoming materials meet specifications. Identify opportunities to improve efficiency, consistency, and product reliability. Requirements:
Bachelor's degree in quality, Manufacturing, Mechanical, or Industrial Engineering (or related field). 5+ years of experience in a quality engineering role (medical device or precision manufacturing preferred). Knowledge of quality management systems (ISO 13485, ISO 9001, or equivalent). Familiarity with FDA regulations and medical device compliance is a plus. Experience with root cause analysis, FMEA, SPC, and CAPA methodologies. Strong understanding of inspection methods, measurement systems, and GD&T. Proficiency with ERP/MRP systems, statistical analysis tools, and Microsoft Office. Excellent communication, problem-solving, and cross-functional collaboration skills.
Develop, implement, and maintain quality systems to ensure compliance with industry standards and customer requirements. Collaborate with engineering and production teams to establish and monitor quality control processes. Support new product introductions by developing inspection plans, test protocols, and validation activities. Perform root cause analysis and lead corrective and preventive action (CAPA) initiatives. Conduct audits of processes, products, and suppliers to verify adherence to quality standards. nalyse data, track metrics, and generate reports to drive continuous improvement. Train and support production staff in quality standards, documentation, and best practices. Partner with supply chain and operations to ensure incoming materials meet specifications. Identify opportunities to improve efficiency, consistency, and product reliability. Requirements:
Bachelor's degree in quality, Manufacturing, Mechanical, or Industrial Engineering (or related field). 5+ years of experience in a quality engineering role (medical device or precision manufacturing preferred). Knowledge of quality management systems (ISO 13485, ISO 9001, or equivalent). Familiarity with FDA regulations and medical device compliance is a plus. Experience with root cause analysis, FMEA, SPC, and CAPA methodologies. Strong understanding of inspection methods, measurement systems, and GD&T. Proficiency with ERP/MRP systems, statistical analysis tools, and Microsoft Office. Excellent communication, problem-solving, and cross-functional collaboration skills.