Quality Engineer (Medical Device) jobs in United States
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Dexian · 1 day ago

Quality Engineer (Medical Device)

Dexian is a leading provider of staffing, IT, and workforce solutions. The Quality Engineer role is dedicated to ensuring the highest quality experiences for patients and customers by providing engineering guidance and expertise to improve process, data, and product quality.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency
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H1B Sponsor Likelynote
Hiring Manager
Prathamesh Waghmode
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Responsibilities

Drive quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and support product complaint technical investigations
Support third-party audits of the site through audit preparation and participation in front/back room discussions
Apply advanced Quality Assurance and Scientific Method principles to daily work
Ensure alignment with regulations, standards, GxP requirements, and industry best practices
Plan and conduct moderately complex projects with high technical responsibility and strategic input
Serve as a subject matter expert (SME) in quality assurance and scientific areas as needed
Lead strategic quality initiatives throughout the organization
Contribute to the development of new projects, programs, and processes
Lead and drive root cause investigations for complaints, NCRs, Deviations, OOS, etc
Represent the organization in projects and communications with internal and external stakeholders, providing expert guidance and solutions

Qualification

Quality AssuranceRegulatory ComplianceRoot Cause AnalysisScientific MethodProject ManagementCommunication SkillsTeam Collaboration

Required

Experience in quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and product complaint technical investigations
Ability to support third-party audits of the site through audit preparation and participation in discussions
Knowledge of advanced Quality Assurance and Scientific Method principles
Understanding of regulations, standards, GxP requirements, and industry best practices
Experience in planning and conducting moderately complex projects with high technical responsibility
Ability to serve as a subject matter expert (SME) in quality assurance and scientific areas
Experience in leading strategic quality initiatives throughout an organization
Ability to contribute to the development of new projects, programs, and processes
Experience in leading and driving root cause investigations for complaints, NCRs, Deviations, OOS, etc
Ability to represent the organization in projects and communications with internal and external stakeholders

Company

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

H1B Sponsorship

Dexian 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 (65)

Funding

Current Stage
Late Stage

Leadership Team

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Mahfuz Ahmed
Chairman of the Board
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Vikram Motiani
Managing Director
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Company data provided by crunchbase