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Shoolin Inc · 13 hours ago

Supplier Quality Engineer

positionMassachusetts, United States
timeContract
remoteOnsite
seniorityMid Level
date4+ years exp
Shoolin Inc is seeking a Supplier Quality Remediation Engineer to support supplier remediation activities following FDA regulatory observations. This role focuses on leading supplier gap assessments, driving corrective actions, and ensuring design and process risk controls meet FDA and ISO requirements in regulated manufacturing environments.
Artificial Intelligence (AI)Cloud ComputingBig DataSoftwareInternet of ThingsInformation Technology
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H1B Sponsor Likelynote
Hiring Manager
Aadil Shaikh
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Responsibilities

Lead supplier gap assessments and remediation activities
Evaluate supplier process controls and identify high-severity risks
Drive corrective actions aligned with FDA and ISO expectations
Review and support supplier validation and qualification activities
Collaborate directly with suppliers and internal stakeholders to sustain compliance

Qualification

Supplier quality experienceDFMEAPFMEA expertiseProcess validation experienceFDA QSR knowledgeStatistical tools (Minitab)Process capability analysisMeasurement System AnalysisBachelor’s degree in EngineeringISO 13485 knowledgeISO 14971 knowledge

Required

Bachelor's degree in Engineering
4+ years of experience in Medical Device or regulated manufacturing environments
Hands-on supplier quality and remediation experience
Support of FDA 483 observations and remediation activities
Strong expertise in dFMEA and pFMEA (severity-focused risk assessment)
Process validation experience (IQ / OQ / PQ)
Process capability analysis (Cp / Cpk)
Measurement System Analysis (MSA / Gage R&R)
Working knowledge of FDA QSR, ISO 13485, and ISO 14971
Experience using statistical tools (e.g., Minitab)

Company

Shoolin Inc

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Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
dateFounded in 2010
location
Iselin, New Jersey, USA
people-size51-200 employees
web-link
https://shoolin-inc.com

H1B Sponsorship

Shoolin Inc has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (45)
2023 (48)
2022 (36)
2021 (29)
2020 (18)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase