Intellectt Inc ยท 2 days ago
Supplier Quality Engineer (medical device)
California, United States
Contract
Onsite
Mid LevelIntellectt Inc is seeking a Supplier Quality Engineer to support supplier qualification and ongoing supplier performance for complex Class II/III medical devices. This role involves working cross-functionally with various departments to ensure quality and compliance throughout the supply chain.
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Hiring Manager
Venkat Chinta
Responsibilities
Lead supplier part qualification to support development and commercial launch schedules
Execute supplier process validations (IQ/OQ/PQ) and capability studies
Conduct GR&R studies, SPC monitoring, and statistical analysis
Develop test methods, inspection plans, and measurement fixtures
Support creation and revision of component specifications, print reviews, and GD&T interpretation
Analyze and disposition supplier nonconformances
Lead root cause investigations and drive corrective/preventive actions (CAPAs/SCARs)
Provide technical support to Receiving Inspection and manufacturing
Plan, schedule, and perform on-site supplier audits (process, QMS, special process)
Assess supplier compliance to FDA QSR 21 CFR Part 820, ISO 13485, ISO 9001
Prepare audit reports, identify gaps, and verify corrective action implementation
Evaluate supplier risk level and maintain approved supplier records
Conduct supplier monitoring and re-evaluation audits as required
Support PFMEA, process control plans, and supplier quality agreements
Monitor supplier performance metrics and present risks to leadership
Identify and execute continuous improvement projects using Lean/Six Sigma techniques
Qualification
Required
Experience in supplier qualification for complex Class II/III medical devices
Knowledge of process validation (IQ/OQ/PQ) and capability studies
Experience conducting GR&R studies, SPC monitoring, and statistical analysis
Ability to develop test methods, inspection plans, and measurement fixtures
Experience in creating and revising component specifications, print reviews, and GD&T interpretation
Ability to analyze and disposition supplier nonconformances
Experience leading root cause investigations and driving corrective/preventive actions (CAPAs/SCARs)
Technical support experience to Receiving Inspection and manufacturing
Experience planning, scheduling, and performing on-site supplier audits (process, QMS, special process)
Knowledge of FDA QSR 21 CFR Part 820, ISO 13485, ISO 9001 compliance
Ability to prepare audit reports, identify gaps, and verify corrective action implementation
Experience evaluating supplier risk levels and maintaining approved supplier records
Experience conducting supplier monitoring and re-evaluation audits as required
Support experience for PFMEA, process control plans, and supplier quality agreements
Ability to monitor supplier performance metrics and present risks to leadership
Experience identifying and executing continuous improvement projects using Lean/Six Sigma techniques
Company
Intellectt Inc
Intellectt Inc.
Founded in 2018
1001-5000 employees
H1B Sponsorship
Intellectt 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
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Trends of Total Sponsorships
2025 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)
Funding
Current Stage
Late StageCompany data provided by crunchbase