INGENYX- Manufacturing Quality Engineer III

Teleflex•Mansfield, MA

2d•$110,500 - $138,100

About The Position

The Manufacturing Quality Engineer III is a hands-on engineering role supporting manufacturing operations through process monitoring, equipment oversight, validation activities, calibration compliance, and continuous improvement. The position partners with Manufacturing, Operations, Engineering, and Quality teams to strengthen processes, improve product quality, reduce variation, and maintain compliance with applicable quality-system and regulatory requirements. The role involves substantial time on the manufacturing floor evaluating processes, equipment performance, process controls, and validation effectiveness. The engineer leads technical investigations and improvement initiatives and supports process and equipment validation, calibration programs, product and process transfers, and operational excellence activities. Ingenyx is a global provider of product development and production services for medical device manufacturers, with capabilities spanning engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly, and packaging. Expected travel is up to 25%.

Requirements

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Biomedical Engineering, or a 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.
Demonstrated experience leading technical investigations and process improvement initiatives.
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 of 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.

Nice To Haves

Experience in medical device manufacturing.
Experience with statistical analysis and process capability techniques.
Experience with data analysis tools such as Power BI, QI Macros, advanced Excel, Python, or R.
Experience leading and resolving non-conformances.
Experience authoring quality control plans and performing manufacturing data trending.
Lean Manufacturing and/or Six Sigma certification.

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.
Support equipment qualification, installation, modification, and lifecycle management.
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 involving 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 implement 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 a subject matter expert for manufacturing processes and equipment.
Ensure compliance with 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.