Insulet Corporation
Manager, Operations Quality - NPI Programs (Hybrid - Acton)
US - Massachusetts · Senior
Sponsorship not specified$111k-$166kDetected 17 days ago
Data AnalysisGMPFDA RegulatoryMedical DevicesLeadershipProblem Solving
Stay score
odds of building a lasting career here
57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 85%
Of 13 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
5 transfer filings in the last year, covering 5 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- Join a highly visible leadership role where you will shape quality strategy for next-generation medical device products from early development through commercialization.
Responsibilities
- 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 covering Manufacturing Quality and Supplier Quality activities for NPI programs
- Maintain strong dotted-line relationships with Global Quality Engineering and Global Supplier Quality to ensure alignment with enterprise standards, escalation paths, and functional best practices
- Own quality engineering workstreams for prototype, pilot, clinical, and early production builds, ensuring compliance with design controls, supplier controls, and quality system requirements
- Define and implement inspection, test, incoming quality, and supplier release strategies for development and clinical stage builds
- Establish and maintain control plans, procedures, work instructions, inspection plans, supplier quality plans, and acceptance criteria to support evolving pilot line and supplier processes
- Lead in-process, incoming, and supplier inspection strategies, including test method development, validation, measurement system analysis, and component release readiness
- Drive root cause investigation, non-conformance disposition, supplier quality issue resolution, and corrective actions across development builds, pilot operations, and supplied components
- Partner with suppliers, R&D, Manufacturing Engineering, Operations, and Quality functions to ensure designs, supplied components, and manufacturing processes are manufacturable, inspectable, scalable, and compliant
- Perform data analysis and trending to inform design decisions, supplier performance, process improvements, and risk mitigation
Requirements
- Experience with development-phase quality engineering, including design controls, DHF/DHR, supplier readiness, and clinical build support
- Role is based in Acton and the ideal candidate will be in office a minimum of 4 days a week
- Ensure builds meet DHF/DHR requirements, including inspection readiness, traceability, lot release, supplier documentation, and quality records required for clinical use
Skills
- Strategic thinker who can translate evolving product, process, and supplier requirements into practical, scalable quality systems
- Demonstrated ability to operate effectively in early-stage, ambiguous development and supplier readiness environments
- Data-driven and detail-oriented, with strong problem-solving, prioritization, and escalation management capability
- 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
- 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
Compensation
- Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $110,900.00 - $166,325.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including
Company info
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
Apply directly at Insulet Corporation →Create a free account for alerts like thisView Insulet Corporation immigration profile
This listing is sourced directly from Insulet Corporation's careers page and normalized into a canonical job model.