Quality Engineer – NPI Programs

Insulet Corporation

. Support quality engineering activities for early-stage product development and pilot manufacturing operations .

Posted 9/25/2026full-timeActon • Massachusetts • United StatesMid-LevelSenior💰 $70,400 - $105,650 per yearWebsite

About the role

Key responsibilities & impact

Support quality engineering activities for early-stage product development and pilot manufacturing operations
Lead quality engineering activities for prototype, pilot, clinical, and development manufacturing builds
Develop and maintain inspection plans, control plans, procedures, work instructions, and quality standards
Define and implement inspection and test methodologies for product development, pilot manufacturing, and release activities
Ensure compliance with design controls, traceability requirements, quality systems, and product documentation
Support Design History File (DHF), Device History Record (DHR), lot release, and clinical build readiness activities
Analyze quality and manufacturing data to identify trends, mitigate risks, and drive continuous improvement
Lead investigations of nonconforming materials and products, perform root cause analysis, and implement CAPA
Facilitate risk management activities, including DFMEA, PFMEA, and process control strategies
Support qualification and validation of manufacturing equipment, inspection systems, test methods, and production processes (IQ/OQ/PQ)
Partner with R&D and Manufacturing Engineering to improve manufacturability, inspectability, reliability, and process capability
Support manufacturing transfer and commercialization through production quality controls and readiness assessments
Ensure compliance with FDA Quality System Regulations, ISO 13485, GMP requirements, and applicable regulatory standards
Recommend inspection methods, sampling plans, acceptance criteria, and quality controls
Evaluate nonconforming materials and products and provide disposition recommendations and corrective actions
Identify, assess, and escalate product, process, and quality risks
Provide quality engineering expertise during design reviews, risk assessments, validation activities, and manufacturing readiness reviews

Requirements

What you’ll need

Bachelor's degree in engineering or a related technical discipline
At least 3 years of Quality Engineering experience in a regulated industry
Experience with inspection methods, metrology systems, test methods, and measurement system analysis
Knowledge of FDA QSR (21 CFR 820) and ISO 13485 quality system requirements
Understanding of design controls, risk management, and medical device quality systems
Familiarity with Design History File (DHF) and Device History Record (DHR) requirements
Experience supporting manufacturing operations, process development, pilot manufacturing, or New Product Introduction (NPI) programs
Experience with equipment and process validation activities (IQ/OQ/PQ)
Knowledge of quality engineering tools, including root cause analysis, statistical analysis, and process capability studies
Strong analytical, problem-solving, and cross-functional collaboration skills
Medical device industry experience preferred
Experience supporting new product development (NPD) programs preferred
Experience with design controls, risk management, and manufacturing quality initiatives preferred
Demonstrated ability to drive quality improvements in a cross-functional environment preferred

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
Additional employee wellness programs
Incentive compensation eligibility