Jobs
>
Niles

    Software Quality Assurance Specialist - Niles, United States - ACL Digital

    ACL Digital
    ACL Digital Niles, United States

    3 weeks ago

    Default job background
    Description
    THE OPPORTUNITY:
    We are looking for a Software Quality Assurance Specialist to join our team. You will work with hardware, application, and other cross-functional teams to react quickly and produce quality solutions to difficult technical challenges. Sibel's fast-paced environment offers ample opportunities for growth in several areas: improved technology skills, effective leadership, dedicated mentorship, creative design, strong communication skills, teamwork, and more.

    WHAT YOU WILL BE WORKING ON:
    • Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the business
    • Work hands-on with quality and compliance activities around Software Development Projects
    • Ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility
    • Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Sibel Health requirements as they relate to the development, verification, validation, maintenance of computerized systems used in the quality system to include those used in the development of software/firmware products.
    • Lead, develop, communicate & implement a quality and compliance strategy
    • Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site
    • Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methods
    • Work with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etc
    • Lead teams through Root Cause Investigations, Risk Assessment Reviews, and the development and execution of Corrective and Preventive Actions (CAPA) as needed to monitor and track the timely resolution of nonconformances to meet tight device production and shipping deadlines.
    • Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions.
    • Utilize risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc
    • Develop process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process
    • Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation
    Qualification:
    • Bachelor's level degree in Science/Engineering/Software or related discipline
    • 6 years of related experience, including 3+ years' experience in Software Quality Assurance and validation
    • Working knowledge of regional and international quality system requirements including IEC 62304, ISO 14971, FDA 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
    • Experience performing internal audits and participating in external audits
    • Attention to detail
    • Effective verbal and written communication skills
  • Topco Associates

    Quality Assurance Specialist

    2 weeks ago

    Topco Associates Itasca, United States

    Overview · Topco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. · Under guid ...

  • North Iowa Area Community College

    Quality Assurance Specialist

    2 weeks ago

    North Iowa Area Community College Chicago, United States

    Quality Assurance Specialist Workforce Innovation and Opportunity Act (WIOA) · QUALITY ASSURANCE SPECIALIST - WORKFORCE INNOVATION AND OPPORTUNITY ACT (WIOA) · CATEGORY/LEVEL: · PSS/5, 12-monthcontract · BASIC FUNCTION: · We are seeking a dedicated andexperienced Quality Ass ...

  • Longenecker & Associates

    Performance Assurance and Improvement Specialist

    2 weeks ago

    Longenecker & Associates Oak Ridge, United States

    Job Description · Job DescriptionOVERVIEW · Longenecker & Associates (L&A), supporting the United Cleanup Oak Ridge (UCOR) LLC contract, is in search of a Performance Assurance Specialist, to support the Contract & Performance Assurance organization. This position reports to the ...

  • Katalyst HealthCares & Life Sciences

    Quality Assurance Specialist

    2 weeks ago

    Katalyst HealthCares & Life Sciences Chicago, United States

    Responsibilities: · Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requi ...

  • Katalyst HealthCares & Life Sciences

    Quality Assurance Specialist

    2 weeks ago

    Katalyst HealthCares & Life Sciences Chicago, United States

    Responsibilities:Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requireme ...

  • Addus HomeCare

    Home Care Quality Assurance Specialist

    3 weeks ago

    Addus HomeCare Chicago, United States Full time

    Requisition #: 5956 · Location: Chicago, IL 60643 · Category: Clerical/Administrative Support · Service Line: Personal Care Services · To apply via text, text 5956 to · Position Summary : The entry level Quality Assurance (QA) Specialist will conduct in-home visits at clie ...

  • Ingredion Incorporated

    Pharmaceutical Quality Assurance Specialist

    3 weeks ago

    Ingredion Incorporated Bedford Park, United States

    As a Pharmaceutical Quality Assurance Specialist, API your responsibilities will include:Perform batch record review on all API and NF batches. Monitor the day-to-day quality activities of the API to produce and package products of sufficient quality Quality Assurance, Assurance, ...

  • Addus HomeCare

    Home Care Quality Assurance Specialist

    3 weeks ago

    Addus HomeCare Chicago, United States

    To apply via text, text 5956 to · Position Summary: The entry level Quality Assurance (QA) Specialist will conduct in-home visits at clients' homes to monitor and report on the quality of services being provided by Home Care Aides, and to determine whether existing care plans a ...

  • Ingredion Inc,

    Pharmaceutical Quality Assurance Specialist

    3 weeks ago

    Ingredion Inc, Bedford Park, United States

    As a Pharmaceutical Quality Assurance Specialist, API your responsibilities will include: · * Perform batch record review on all API and NF batches. · * Monitor the day-to-day quality activities of the API to produce and package products of sufficient quality and quantity that me ...

  • PSG Global Solutions Careers

    Quality Assurance Compliance Specialist

    2 weeks ago

    PSG Global Solutions Careers Waukegan, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Quality Assurance Compliance Specialist, working in Pharmaceuticals and Medical Products industry in Waukegan, Illinois, 60085, United States. ...

  • US Tech Solutions, Inc.

    Quality Assurance Specialist I

    1 week ago

    US Tech Solutions, Inc. North Chicago, United States

    Job Title: Quality Assurance Specialist I (Med Device Complaints) · Location: North Chicago, IL Onsite) · Duration: 6 months contract · Work Schedule: · • First shift, Overtime is offered. · • Some aspects that can be done from home. · Job Description: · Individual will work ...

  • AbbVie

    Specialist, Distribution Quality Assurance

    3 weeks ago

    AbbVie North Chicago, United States

    Job Description · Job DescriptionCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives acr ...

  • Topco Associates

    Quality Assurance Specialist

    2 weeks ago

    Topco Associates Itasca, United States

    Overview · Topco Associates is currently seeking a Quality Assurance Specialist - Product Management for the Quality Assurance team in Itasca, IL. This position will be a hybrid role, with the successful candidate conducting work in our Itasca office and virtually. · Under guid ...

  • Abbott Laboratories company

    Specialist Quality Assurance

    3 weeks ago

    Abbott Laboratories company Chicago, United States

    The Opportunity. This role will conduct quality-related activities in Complaint Handling to deliver consistent high-quality documents, services, products and processes, which adds value to the business. The primary function of the Quality Specialist Quality Assurance, Specialist, ...

  • North Iowa Area Community College

    Quality Assurance Specialist

    2 weeks ago

    North Iowa Area Community College Chicago, United States

    Quality Assurance Specialist – Workforce Innovation and Opportunity Act (WIOA) · QUALITY ASSURANCE SPECIALIST - WORKFORCE INNOVATION AND OPPORTUNITY ACT (WIOA) · CATEGORY/LEVEL: · PSS/5, 12-monthcontract · BASIC FUNCTION: · We are seeking a dedicated andexperienced Quality As ...

  • Ambercare

    Home Care Quality Assurance Specialist

    2 weeks ago

    Ambercare Chicago, United States

    To apply via text, text 5956 to · Position Summary: The entry level Quality Assurance (QA) Specialist will conduct in-home visits at clients' homes to monitor and report on the quality of services being provided by Home Care Aides, and to determine whether existing care plans ar ...

  • Addus

    Quality Assurance Specialist

    3 weeks ago

    Addus Warrenville, United States

    **Job Details** · **Quality Assurance Specialist - Home Care** · **Requisition #:** · **Location:** Warrenville, IL 60555 · **Category:** Clerical/Administrative Support · **Service Line:** Administrative · **Position Summary****:** The Quality Assurance (QA) Specialist wil ...

  • Spectraforce Technologies

    Quality Assurance Specialist

    1 week ago

    Spectraforce Technologies North Chicago, United States

    Job Title: Quality Assurance Specialist · Duration: 6 months · Location/Site: North Chicago IL 60064 · Description: · Describe the primary goals, objectives or functions or outputs of this position. · Individual will work in Post Market QA organization investigating return sample ...

  • Kedplasma Llc.

    Quality Assurance Specialist

    1 week ago

    Kedplasma Llc. Chicago, United States

    Job Description Job Description KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual ...

  • Abbott Laboratories

    Specialist Quality Assurance

    1 week ago

    Abbott Laboratories Chicago, United States

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...