Quality Engineer

What You’ll Do

• 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

• Analyze 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

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What We’re Looking For

• Bachelor’s degree in Quality, Manufacturing, Mechanical, or Industrial Engineering (or related field)

• 3+ 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