INGENYX- Manufacturing Quality Engineer III

Position Summary

Manufacturing Quality Engineer III is a hands-on engineering role responsible for supporting manufacturing operations through process monitoring, equipment oversight, validation activities, calibration compliance, and continuous improvement initiatives. 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 successful candidate will spend significant time on the manufacturing floor evaluating processes, equipment performance, process controls, and validation effectiveness while leading technical investigations and improvement initiatives.

Principal Responsibilities

• Provide day-to-day quality engineering support for manufacturing operations.
• Partner with Manufacturing and Operations teams to monitor and improve process performance, product quality, and manufacturing efficiency.
• Lead and support process validation activities, including TMV, IQ/OQ/PQ, and revalidation efforts.
• Support equipment qualification, installation, modification, and lifecycle management activities.
• Monitor process capability and identify opportunities to reduce variability and improve yield.
• Analyze manufacturing and quality data to identify trends, risks, and improvement opportunities.
• Lead and facilitate technical root cause investigations related to manufacturing processes, equipment performance, and product quality issues.
• Ensure manufacturing processes remain in a validated state through routine monitoring and assessment.
• Oversee calibration programs and ensure measurement systems remain compliant and effective.
• Evaluate inspection methods, measurement systems, and process controls to ensure product requirements are consistently achieved.
• 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.
• Provide technical guidance and mentoring to junior engineers and manufacturing personnel as needed.
• Support nonconformance, CAPA, audit, and compliance activities as subject matter experts for manufacturing processes and equipment.
• Ensure compliance with applicable company procedures, FDA regulations, ISO 13485 requirements, and customer expectations.
• Participate in and propose operational excellence activities to reduce scrap, enhance efficiency, and improve quality.

Education / Experience Requirements

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or related technical discipline.
• Minimum 5-8 years of engineering experience in a regulated manufacturing environment.
• Experience supporting manufacturing equipment, process validation, and calibration systems.
• Strong mechanical aptitude and ability to troubleshoot manufacturing equipment and processes.
• Experience in medical device manufacturing preferred.
• Demonstrated experience leading technical investigations and process improvement initiatives.
• Experience with statistical analysis and process capability techniques preferred.

Specialized Skills / Other Requirements

• Strong understanding of manufacturing processes and equipment.
• Knowledge of process validation methodologies including IQ/OQ/PQ and TMV.
• Experience with calibration systems, measurement systems, and metrology principles.
• Proficiency in root cause analysis tools and problem-solving methodologies.
• Understanding SPC, process capability studies, and data analysis techniques.
• 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.
• Experience leading and resolving non-conformances.
• Experience authoring quality control plans and performing manufacturing data trending preferred.
• Lean Manufacturing and/or Six Sigma certification are preferred.