Quality Engineer with medical device or Auto, IQ/OQ/PQ, quality systems jobs in United States
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Entegee · 9 hours ago

Quality Engineer with medical device or Auto, IQ/OQ/PQ, quality systems

positionVicksburg, MI
timeContract
remoteOnsite
seniorityMid, Senior Level
money$34/hr - $41/hr
date2+ years exp

Entegee is seeking a highly skilled Quality Engineer with expertise in engineering drawing review, GD&T, and quality systems relevant to the automotive, consumer, and medical product industries. This role involves ensuring product quality and regulatory compliance through validation activities and adherence to industry standards.

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H1B Sponsor Likelynote

Responsibilities

Interpret and review complex engineering drawings and specifications, applying expert-level understanding of GD&T to assess product and process compliance
Support and perform medical product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Characterization (PC)
Ensure compliance with industry-specific standards including:
IATF 16949 (Automotive Quality Management Systems)
ISO 9001 (Quality Management Systems)
Medical device quality and regulatory requirements

Qualification

Quality EngineeringGD&TIATF 16949ISO 9001Medical validation protocolsEngineering drawing reviewProcess CharacterizationCollaborationDetail-orientedHands-on

Required

Bachelor's degree in mechanical, Industrial, Manufacturing Engineering, or related technical field
2–5+ years of experience in a Quality Engineering role within the automotive, consumer, or medical product industry
Strong proficiency in engineering drawing review and GD&T
In-depth knowledge of IATF 16949, ISO 9001, and medical validation protocols (IQ, OQ, PQ, PC)

Benefits

Medical
Dental
Vision
Term life insurance
Short-term disability insurance
Additional voluntary benefits
Commuter benefits
401K plan
Paid Sick Leave
Holiday pay

Company

Entegee

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Entegee is a staffing and recruiting company providing contract engineers and technical specialists.
dateFounded in 1958
location
Burlington, Massachusetts, USA
people-size201-500 employees
web-link
http://entegee.com

H1B Sponsorship

Entegee 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 (5)
2024 (2)
2023 (1)
2022 (4)
2021 (8)
2020 (5)

Funding

Current Stage
Growth Stage

Leadership Team

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Bob Bolster
Chief Operating Officer
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Company data provided by crunchbase