Quality Assurance Specialist jobs in Aurora, IL

Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Quality Assurance Specialist
  • EdgeOne Medical
  • Wheeling, IL FULL_TIME
  • Function: Quality

    Summary

    EdgeOne Medical is seeking a Quality Assurance Specialist to join our growing organization. This role includes maintenance and optimization of the QMS to Medical Device standards.

    Please send your resume and a cover letter to careers@edgeonemedical.com and include Quality Assurance Specialist in the Title.

    Essential Duties and Responsibilities

    • Implementation and validation of an e-Quality Management System.
    • Lead the maintenance, performance monitoring and continual improvement of the QMS.
    • Establish standards of performance within the QMS.
    • Direct support internal and external audits; quality system certifications/accreditations and facility registrations.
    • Lead Quality activities for CAPA and Change Management.
    • Lead QMS process improvement initiatives and implementation.
    • Support other Process Improvement initiatives across the business.
    • Support development and lead implementation of SaMD QMS requirements
    • Support internal identification and development of processes and tools required for client service offerings relating to design and development of SaMD (digital app & software) and connected Medical Devices.
    • Lead evaluation/customization, implementation, and validation of E1M’s own service enabling software tool(s).
    • Support E1M clients with QMS consulting and services for Medical Devices.

    Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

    • Bachelor or advanced degree in Engineering or Life Science.
    • Expert knowledge and interpretation of ISO 13485:2016 and 21CFR820
    • Experience in validation and maintenance of regulated software devices, apps and tools.
    • Strong knowledge of GDP, GLP and GMP
    • Familiarity with ISO 17025, Medical Device Regulation 2017/745 and MDSAP
    • Well-organized with strong communication and management skills.
    • Minimum of 5 years of experience demonstrating knowledge of a wide range of Quality Systems activities specifically in medical device quality systems.

    Equal Employment Opportunity

    Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.

  • 20 Days Ago

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Quality Assurance Specialist
  • BEPC Inc
  • Carol Stream, IL FULL_TIME
  • BEPC is actively looking for a Quality Assurance Specialist in the Carol Stream, Illinois area!! 4-month contract with possible temp to hire Benefits include medical, dental, vision, and life Pay Rate...
  • 21 Days Ago

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Quality assurance specialist
  • Innova Solutions
  • Skokie, IL FULL_TIME
  • Innova Solutions is immediately hiring for a QA Specialist 2 shift Position type : Full Time Position Location : Skokie, IL As a QA Specialist you will : Responsible for reporting any food safety and ...
  • 22 Days Ago

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Quality Assurance Specialist
  • Underground Administration
  • Des Plaines, IL FULL_TIME
  • Salary Range: $60,000 - $70,000 Our client, a privately held software company, is seeking an experienced Quality Assurance (QA) Analyst. In this role, you will be responsible for testing software to i...
  • 3 Days Ago

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Quality Assurance Specialist
  • Batory Foods
  • Village, IL FULL_TIME
  • At Batory Foods, we encourage our team to Bring YOU, Every Day because true success starts with the ability to be yourself and letting your unique talents shine. Since 1979, the heart of our success h...
  • 3 Days Ago

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Quality Assurance Specialist
  • DuPagePads
  • Wheaton, IL FULL_TIME
  • Quality Assurance Specialist Summary: This position is responsible for providing administrative support to the Supportive Housing Program in the departmental operations, including oversight of partici...
  • 13 Days Ago

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0 Quality Assurance Specialist jobs found in Aurora, IL area

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REMOTE - QUALITY ASSURANCE SPECIALIST, (LMS)
  • Softworld, a Kelly Company
  • Chicago, IL
  • Quality Assurance Specialist (LMS Systems) Remote - PST Time Zone Only $35/hr What are the top 3 things you are looking ...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Specialist
  • Accuity
  • Chicago, IL
  • Job Type Full-time Description The Quality Assurance (QA) Specialist is responsible for performance of internal coding Q...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Specialist - Home Care
  • Addus
  • Warrenville, IL
  • **Job Details** **Quality Assurance Specialist - Home Care** **Requisition #:** 21-1731 **Location:** Warrenville, IL 60...
  • 3/29/2024 12:00:00 AM

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Quality Assurance Specialist - Product Management (Hybrid)
  • Topco Associates LLC
  • Itasca, IL
  • Topco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team...
  • 3/29/2024 12:00:00 AM

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Senior Quality Assurance Specialist
  • Pegasus Knowledge Solutions, Inc.
  • Chicago, IL
  • We are partnering with our client for filling a contract position of Manual QA Tester with expertise working in the fina...
  • 3/28/2024 12:00:00 AM

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Sr. Quality Assurance Specialist
  • HR Director
  • Addison, IL
  • Job Description Job Description Sr. Quality Assurance Specialist – Addison, IL $80,000-$120,000 D.O.E., Full Benefits As...
  • 3/28/2024 12:00:00 AM

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Home Care Quality Assurance Specialist- Bilingual Spanish
  • Addus
  • Chicago, IL
  • **Job Details** **Home Care Quality Assurance Specialist- Bilingual Spanish** **Requisition #:** 21-1707 **Location:** C...
  • 3/28/2024 12:00:00 AM

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Quality Assurance Specialist - Product Management (Hybrid)
  • Topco Associates
  • Itasca, IL
  • Overview: Topco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assu...
  • 3/26/2024 12:00:00 AM

Aurora, a suburb of Chicago, is a city in DuPage, Kane, Kendall, and Will counties in the U.S. state of Illinois. Located primarily in DuPage and Kane counties, it is an outer suburb of Chicago and the second most populous city in the state, and the 114th most populous city in the country. The population was 197,899 at the 2010 census, and was estimated to have increased to 200,965 by 2017. Once a mid-sized manufacturing city, Aurora has grown since the 1960s. Founded within Kane County, Aurora's city limits and population have expanded into DuPage, Will, and Kendall counties. Between 2000 an...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$64,134 to $81,194
Aurora, Illinois area prices
were up 0.8% from a year ago

Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020