Quality Engineer

Company : Katalyst Healthcares & Life Sciences

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.
• Analyse 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.

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