Quality Engineer(ISO-13485) jobs in United States
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Confidential · 1 day ago

Quality Engineer(ISO-13485)

Confidential is a state of the art technical manufacturing company on Long Island looking to hire a Quality Engineer to join the team. The role involves ensuring compliance with standards, identifying issues, recommending solutions, and creating quality documentation.

Marketing & Advertising

Responsibilities

Validations & PPAP (IQ/OQ/PQ, Control Plan, Process Flow Chart, Gage R&R, etc.)
Conduct sample size determination, statistical analysis, training, and root cause analysis
Take lead in process failure modes and effects analysis (FMEA)
Manage and contribute to problem solving teams using standardized investigation processes/tools
Change Control Specs, Materials
Assist with the preparation in technical reviews of products
Participate in Customer and Regulatory body audits
Other tasks and duties as assigned

Qualification

Quality documentationFMEASPCSix SigmaLean manufacturingSAPAnalytical skillsProblem solvingProject managementInterpersonal skillsCommunication skills

Required

Bachelor's degree in engineering or related field (desired)
Ability to solve routine design and engineering tasks with some assistance
Basic understanding of engineering and mathematics principles
Understand interpretation of drawings, specifications, blueprints, etc
Strong analytical, problem solving, and teamwork skills
Excellent time management, prioritization abilities, and strong project management skills
New strategies development
Ability to work with and manage complexity/change
Demonstrated ability to make tough decisions
Excellent interpersonal, communication, and presentation skills
Corrective action follows through with suppliers
Personally driven and motivates others to excel
Familiar with SPC, Six Sigma, Process Capability Study
Experience with Continuous improvement
Lean manufacturing
Ability to use MS Office Tools such as Word, Excel, and SAP
Confidence and ability to make recommendations as needed

Benefits

401(k)
401(k)match
Medical insurance
Paid time off
Employee referral
Voluntary Benefits
STD/LTD Disability
Life Insurance
Pet Insurance
Discount on vendor products

Company

Confidential

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This page is owned and operated by JAF HOLDINGS INC. All rights reserved 2025. jafholdingsinc.com

Funding

Current Stage
Growth Stage

Leadership Team

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Roshan Syed
Global Talent Partner
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Company data provided by crunchbase