QA Specialist II and III jobs in United States
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ICONMA · 1 week ago

QA Specialist II and III

positionDes Plaines, IL
timeFull-time
remoteOnsite
seniorityMid, Senior Level
money$32.22/hr - $34.03/hr
date5+ years exp

ICONMA is a company in the Medical Device and Healthcare sector, seeking a QA Specialist II and III for their Des Plaines, IL location. The role involves working with cross-functional teams to review qualification and validation documents, supporting the qualification and validation process for new manufacturing and automation projects.

Staffing & Recruiting
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H1B Sponsor Likelynote

Responsibilities

Works with a cross functional team to review qualification and validation documents which meet Client and regulatory requirements
Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, test method validations in support of a manufacturing expansion
Especially in HPLC synthesis, purification and testing
Supports on-market change control projects

Qualification

FDA knowledgeGMP knowledgeISO 13485 knowledgeISO 14971 knowledgeQuality experienceEngineering degreeTechnical writingVerbal communicationWritten communication

Required

Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience
At least 5 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes
Bachelor's or master's degree in one of the following Engineering disciplines: Chemical, Electrical, Bio-medical, or Mechanical
5+ years of relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Strong technical writing skills
Polished verbal and written communication skills

Benefits

Health Benefits
Referral Program

Company

ICONMA

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ICONMA: Your Partner in Global Staffing Solutions and Digital Transformation ICONMA is a globally recognized, Woman-Owned staff augmentation and technology consulting firm.
dateFounded in 2000
location
Troy, MI, US
people-size1001-5000 employees
web-link
http://www.iconma.com

H1B Sponsorship

ICONMA 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 (34)
2024 (31)
2023 (26)
2022 (39)
2021 (37)
2020 (69)

Funding

Current Stage
Late Stage

Leadership Team

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Claudine George
Founder and CEO of ICONMA, LLC
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Company data provided by crunchbase