Quality Engineer jobs in United States
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Unicon Pharma Inc ยท 1 day ago

Quality Engineer

positionNebraska, United States
timeFull-time
remoteOnsite
seniorityMid Level
date3+ years exp

Unicon Pharma Inc is focused on the development and engineering of medical devices, and they are seeking a Quality Engineer II to support new product development and ensure compliance with quality standards. The role involves collaborating with cross-functional teams to analyze processes, drive continuous improvement, and resolve quality issues using data-driven methods.

BiotechnologyMedicalPharmaceutical
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Navya Matha
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Responsibilities

Provide quality engineering support for product development and sustaining projects
Apply tools such as root cause analysis, FMEA, risk management, DOE, validation, MSA, and control plans
Ensure compliance with quality policies, procedures, and regulatory standards
Review/approve validation and change-control protocols and reports
Monitor process performance and lead continuous improvement using Lean/Six Sigma

Qualification

Quality engineeringValidation experienceStatistical analysisMinitabLean/Six SigmaMedical device qualityASQ CQE/CQA certification21 CFR complianceISO 13485 knowledgeProblem-solving skillsProject management

Required

B.S. in Engineering (Industrial, Mechanical, or similar)
3+ years of quality engineering and validation experience
Strong statistical/problem-solving skills; proficiency in Minitab and MS Office
Solid understanding of medical-device quality and validation principles

Preferred

Experience with failure analysis, test methods, and tolerances
Six Sigma certification; ASQ CQE/CQA preferred
Knowledge of 21 CFR 820/210/211 and ISO 13485
Project management experience

Company

Unicon Pharma Inc

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Unicon Pharma provides customized workforce solutions for life sciences companies, bringing innovative treatments from concept to reality.
dateFounded in 2013
location
South Plainfield, New Jersey, USA
people-size201-500 employees
web-link
https://www.uniconpharma.com/

H1B Sponsorship

Unicon Pharma 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 (71)
2024 (58)
2023 (71)
2022 (80)
2021 (91)
2020 (87)

Funding

Current Stage
Growth Stage

Leadership Team

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Ravi Kollipara
CEO
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Company data provided by crunchbase