INGENYX- Quality Engineering Technician

Position Summary

Quality Engineering Technician is a hands-on engineering support role responsible for planning and executing process monitoring, equipment oversight, validation activities, and continuous improvement initiatives with guidance from Quality Engineering. This position works closely with Manufacturing, Operations, Engineering, and Quality teams to drive process robustness, improve product quality, reduce variation, and ensure compliance with applicable quality system and regulatory requirements.

The ideal candidate is capable of decisive, swift and precise execution of change with an eye for detail & improvement and brings with them an enthusiastic demeanor.

Principal Responsibilities

• Provide day-to-day quality support for engineering operations. Track and communicate project status.
• Assist in quality engineering tasks, such as: data analysis, investigations into potential non-conformance or complaints, or validation activities (TMV, IQ/OQ/PQ).
• Author or co-author engineering, validation, and/or qualification protocols and reports.
• Quality support functions include execution or preparation of quality plans, documentation retrieval during audits, qualification/validation protocols and reports, routing/review/revision of documentation as needed.
• Support manufacturing by reviewing production documentation for completeness and correctness.
• Submit or fulfill engineering change orders, including process change or improvement activities.
• Acquire and analyze manufacturing and quality data to identify trends, risks, and improvement opportunities.
• Assist in technical root cause investigations related to manufacturing processes, equipment performance, and product quality issues.
• Assist in maintenance of the calibration program, including investigation of calibration abnormalities or filing of metrological paperwork.
• Collaborate with Manufacturing Engineering on equipment, tooling, automation, and process improvement projects.
• Participate in risk assessments and implementation of risk mitigation activities.
• Support transfer of new products and processes into manufacturing.
• Participate in and propose operational excellence activities to reduce scrap, enhance efficiency, and improve quality.
• Ensure compliance with applicable company procedures, FDA regulations, ISO 13485 requirements, and customer expectations.
• Updates procedures, work instructions, or other documentation, and leads change orders to execute updates as needed.

Education / Experience Requirements

• Associate's or Bachelor's Degree in Engineering, or related technical discipline.
• Minimum 1 year of quality or manufacturing experience in a regulated environment.
• Preferred: Experience supporting manufacturing, calibration, or quality systems.
• Preferred: Experience in medical device manufacturing.
• Preferred: Experience with data analysis, non-conformance investigation, and authoring of protocols and reports.

Specialized Skills / Other Requirements

• Knowledge of root cause analysis tools and problem-solving methodologies.
• Knowledge of FDA QMSR, ISO 13485, and cGMP requirements.
• Ability to work effectively in cross-functional teams and communicate technical information clearly.
• Strong organizational, analytical, and problem-solving skills.
• Proficiency in Microsoft Office applications and data analysis tools, such as Power BI, QI Macros, Excel (advanced), Python, or R.
• Preferred: Understanding of SPC, process capability studies, and data analysis techniques.
• Preferred: Experience with handling non-conformances.