Manager, Operations Quality – NPI Programs

Insulet Corporation

. Serve as the Operations Quality lead for Manufacturing Quality and Supplier Quality Engineering support across early-stage development, supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer .

Posted 10/3/2026full-timeActon • Massachusetts • United StatesMid-LevelSenior💰 $110,900 - $166,325 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Operations Quality and Supplier Quality Engineering, with a strong focus on compliance with FDA QSR, ISO 13485, and GMP standards. Proven ability to lead cross-functional teams in quality assurance activities for manufacturing and supplier processes, ensuring product readiness and regulatory adherence.

Highest-signal resume keywords

Quality Engineering LeadershipManufacturing Quality ManagementSupplier Quality EngineeringRegulatory Compliance ExpertiseData Analysis and Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality EngineeringManufacturing QualitySupplier QualityInspection Method ValidationMeasurement System AnalysisDesign ControlsDHF/DHR ManagementNPI Program SupportRoot Cause AnalysisCorrective Action Implementation

Soft Skills

People LeadershipProblem-SolvingCross-Functional CollaborationAnalytical SkillsExecution Skills

Tools & Technologies

Inspection TechnologiesMetrologyVision SystemsSupplier Inspection MethodsCleanroom Environment Operations

Industry Keywords

FDA QSR (21 CFR 820)ISO 13485GMPMedical Device ManufacturingSupplier Quality Requirements

About the role

Key responsibilities & impact

Serve as the Operations Quality lead for Manufacturing Quality and Supplier Quality Engineering support across early-stage development, supplier readiness, pilot manufacturing, clinical builds, and manufacturing transfer
Build, manage, and develop a small team responsible for Manufacturing Quality and Supplier Quality activities for NPI programs
Maintain dotted-line relationships with Global Quality Engineering and Global Supplier Quality
Own quality engineering workstreams for prototype, pilot, clinical, and early production builds
Define and implement inspection, test, incoming quality, and supplier release strategies
Establish and maintain control plans, procedures, work instructions, inspection plans, supplier quality plans, and acceptance criteria
Ensure builds meet DHF/DHR requirements, including inspection readiness, traceability, lot release, supplier documentation, and quality records
Lead in-process, incoming, and supplier inspection strategies, including test method development, validation, measurement system analysis, and component release readiness
Drive root cause investigations, non-conformance disposition, supplier quality issue resolution, and corrective actions
Partner with suppliers, R&D, Manufacturing Engineering, Operations, and Quality functions to ensure designs, components, and processes are manufacturable, inspectable, scalable, and compliant
Perform data analysis and trending to inform design decisions, supplier performance, process improvements, and risk mitigation
Support risk management activities, including DFMEA, PFMEA, supplier risk assessments, and control strategies
Support validation of pilot line equipment, supplier processes, inspection methods, and manufacturing processes
Define and execute Operations Quality strategy for transition into commercial production
Train and guide cross-functional teams while ensuring FDA, ISO 13485, supplier quality, and GMP compliance
Own Operations Quality strategy and decision-making for inspection approaches, supplier quality plans, control frameworks, acceptance criteria, non-conforming product disposition, escalations, and readiness gaps

Requirements

What you’ll need

BS in Engineering or related technical discipline with 6+ years of experience in quality engineering, manufacturing quality, supplier quality, or operations quality in a regulated industry
Prior people leadership, technical leadership, or demonstrated ability to build and lead a small cross-functional quality team
Experience supporting NPI programs, pilot line operations, supplier readiness, and development builds required
Medical device experience strongly preferred, particularly supporting design controls, clinical builds, supplier quality, and manufacturing transfer
Experience leading Manufacturing Quality and/or Supplier Quality Engineering activities in a regulated manufacturing environment
Expertise in inspections, incoming quality, supplier quality controls, test method validation, and measurement system analysis
Experience with development-phase quality engineering, including design controls, DHF/DHR, supplier readiness, and clinical build support
Working knowledge of FDA QSR (21 CFR 820), ISO 13485, GMP, and supplier quality requirements
Experience supporting manufacturing, process development, supplier development, and early-stage production environments
Familiarity with equipment, process, inspection method, and supplier process validation activities
Experience working with inspection technologies, metrology, vision systems, supplier inspection methods, and incoming acceptance processes
Strong analytical, problem-solving, people leadership, and cross-functional execution skills
Able to work in a Class 8 Cleanroom Environment as needed
Travel up to 10%, including international travel to equipment vendors and manufacturing sites

Benefits

Comp & perks

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