INGENYX- Quality Engineering Technician

Teleflex•Mansfield, MA

About The Position

The 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. The position works closely with Manufacturing, Operations, Engineering, and Quality teams to improve process robustness and product quality, reduce variation, and ensure compliance with applicable quality-system and regulatory requirements. The ideal candidate executes changes decisively, swiftly, and precisely, pays close attention to detail and improvement, and brings an enthusiastic demeanor. Ingenyx is a global provider of product development and production services for medical device manufacturers. Its capabilities include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly, and packaging. The company develops solutions including extrusions, diagnostic and interventional catheters, balloons and balloon catheters, sheath/dilator sets, specialty sutures, braids and fibers, and bioabsorbable sutures, yarns and resins.

Requirements

Associate’s or bachelor’s degree in Engineering or a related technical discipline.
At least 1 year of quality or manufacturing experience in a regulated environment.
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, advanced Excel, Python, or R.

Nice To Haves

Experience supporting manufacturing, calibration, or qualification systems.
Experience in medical device manufacturing.
Experience with data analysis, non-conformance investigation, and authoring protocols and reports.
Understanding of SPC, process capability studies, and data-analysis techniques.
Experience handling non-conformances.

Responsibilities

Provide day-to-day quality support for engineering operations and track and communicate project status.
Assist with quality engineering tasks, including data analysis, investigations into potential non-conformances or complaints, and validation activities such as TMV and IQ/OQ/PQ.
Author or co-author engineering, validation, and qualification protocols and reports.
Prepare or execute quality plans; retrieve documentation during audits; prepare qualification and validation protocols and reports; and route, review, or revise documentation as needed.
Support manufacturing by reviewing production documentation for completeness and correctness.
Submit or fulfill engineering change orders, including process changes and improvement activities.
Acquire and analyze manufacturing and quality data to identify trends, risks, and improvement opportunities.
Assist with technical root-cause investigations involving manufacturing processes, equipment performance, and product quality issues.
Assist in maintaining the calibration program, including investigating calibration abnormalities and filing metrological paperwork.
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.
Participate in and propose operational excellence activities to reduce scrap, enhance efficiency, and improve quality.
Ensure compliance with company procedures, FDA regulations, ISO 13485 requirements, and customer expectations.
Update procedures, work instructions, and other documentation, and lead change orders to implement updates.