Software Quality Assurance Specialist

21 hours ago


Niles, United States ACL Digital Full time
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


  • Niles, Illinois, United States Addus HomeCare Full time

    Overview:Addus HomeCare is a leading provider of in-home care services. As a Quality Assurance Specialist, you will have the opportunity to make a real difference in the lives of our clients while contributing to our mission of delivering exceptional care.Job Summary:The Quality Assurance Specialist is responsible for ensuring that our clients receive the...


  • Niles, Illinois, United States Ambercare Full time

    As a Quality Assurance Specialist at Addus HomeCare, you will play a vital role in ensuring the highest level of care for our clients. Your responsibilities will include conducting in-home visits to evaluate the quality of services provided by Home Care Aides, monitoring client's condition and performance of duties, and managing expired licenses items in the...


  • Niles, Illinois, United States Ambercare Full time

    The role of a Quality Assurance (QA) Specialist is crucial in ensuring the quality of services provided by Home Care Aides. As a QA Specialist, you will conduct in-home visits to monitor and report on the quality of services, determine whether existing care plans are adequate, and identify areas for improvement.Key Responsibilities:Monitor Client's...


  • Niles, Illinois, United States Addus HomeCare Full time

    Job Description:As a Quality Assurance Specialist, you will play a vital role in ensuring the highest standards of care are delivered to our clients. Your primary responsibility will be to conduct home visits, monitor client condition and performance of duties by Home Care Aides, and evaluate compliance with all Medicare, Medicaid, and HIPAA regulations.Key...


  • Niles, Illinois, United States Aerotek Full time

    Job SummaryAerotek seeks a skilled Quality Inspector to join its team in Niles, IL.The ideal candidate will possess excellent inspection skills and the ability to work effectively in a fast-paced production environment.About the JobThis is a fully onsite position responsible for performing product inspections, measuring packaging materials, and maintaining...


  • Niles, United States Shure Incorporated Full time

    Manager, Test Engineering (Hardware, Firmware, Software)Job ID 2024-3875Category Software EngineeringJob LocationsUS-IL-NilesWorkplace Arrangement On-siteOverviewShure is looking for a Manager, Test Engineering that will focus on product testing, encompassing Hardware, Firmware, and Software. Would you like join a team who specializes in Product and...


  • Niles, United States Shure Full time

    OverviewShure is looking for a Manager, Test Engineering that will focus on product testing, encompassing Hardware, Firmware, and Software. Would you like join a team who specializes in Product and Software testing to ensure quality assurance of our industry-leading audio products? Then this exciting role is for you! Shure has a range of exciting projects in...


  • Niles, Illinois, United States Addus HomeCare Full time

    About Us:Addus HomeCare is a company dedicated to providing exceptional in-home care services. Our team of professionals is committed to delivering high-quality care to our clients, and we are seeking a Quality Assurance Specialist to join our team.Job Description:The Quality Assurance Specialist will be responsible for ensuring that our clients receive the...


  • Niles, Illinois, United States Shure Incorporated Full time

    **Job Summary**We are seeking a highly skilled Backend Engineer Specialist to join our team. As a Backend Engineer Specialist, you will be responsible for designing, coding, testing, debugging, and documenting platform-independent middleware solutions.About the RoleIn this role, you will work closely with business partners to define requirements for system...


  • Niles, United States Shure Incorporated Full time

    Senior Engineer, Software Implementation (Machine Learning and Audio)Job ID 2024-3894Category Software EngineeringJob LocationsUS-IL-NilesWorkplace Arrangement Hybrid, On-site, RemoteOverviewThe Senior Engineer, Software (Machine Learning and Audio) is responsible for implementing audio functionality, including machine learning algorithms and Digital...


  • Niles, United States Shure Full time

    Overview The Senior Engineer, Software (Machine Learning and Audio) is responsible for implementing audio functionality, including machine learning algorithms and Digital Signal Processing, in applications and in embedded hardware architectures for products in development as well as functional prototypes. Part of a machine learning and artificial...


  • Niles, Illinois, United States Shure Incorporated Full time

    About Our CompanyShure Incorporated is a leading global manufacturer of audio equipment known for quality, reliability, and durability. Founded in 1925, we've been striving for perfection and innovating every chance we get. Our talented teams aim to create exceptional products that exceed customer expectations.The OpportunityWe're looking for a skilled UX...

  • Quality Auditor

    6 days ago


    Niles, United States Mauser Packaging Solutions Full time

    Responsibilities  Performs quality assurance testing as required in the test plan following Q.W.I for methodology. Performs additional testing as required by Q.W.I or supervisory personnel. Reviews production orders or schedules to ascertain product data such as types, quantities and specifications of plastic containers to coordinate department...


  • Niles, Illinois, United States Ambercare Full time

    Addus HomeCare is seeking a highly skilled Quality Assurance Specialist to join our team. As a QA Specialist, you will be responsible for ensuring the quality of services provided by Home Care Aides, monitoring client's condition and performance of duties, and managing expired licenses items in the branch.Key Responsibilities:Monitor Client's Condition:...


  • Niles, Ohio, United States Recruiting Solutions Full time

    Job DescriptionWe are seeking a highly motivated and experienced Administrative Practice Lead to join our team at Recruiting Solutions. As a key member of our operations team, you will be responsible for overseeing the administrative functions of our medical offices.Key ResponsibilitiesAdministrative Leadership: Provide strategic direction and oversight to...


  • Niles, Michigan, United States CAREWATCH OF MICHIGAN HOME CARE Full time

    Job OverviewCareWatch of Michigan Home Care is a leading provider of in-home care services, dedicated to delivering exceptional support and companionship to our clients. As a Caregiving Support Specialist, you will play a vital role in enhancing the quality of life for our clients by providing personalized assistance with daily living tasks.


  • Niles, Michigan, United States HealthCare Support Full time

    Healthcare Support is seeking skilled healthcare specialists to work on local contracts in Niles, Michigan. As a dialysis nurse, you will be responsible for providing high-quality patient care and developing strong relationships with your patients.Key ResponsibilitiesProvide direct patient care in a dialysis settingDevelop and implement individualized care...


  • Niles, Illinois, United States Aerotek Full time

    Job Overview">We are seeking a skilled Trailer Repair Specialist to join our team at Aerotek. As a Trailer Repair Specialist, you will play a critical role in ensuring the safe and efficient operation of trailers by performing repairs and maintenance tasks.">About the Job">This is a challenging and rewarding role that requires a strong understanding of...


  • Niles, United States Shure Incorporated Full time

    Specialist II, Product Management (Packaging and Sustainability) Job ID 2024-3933 Category Marketing & Product Management Job Locations US-IL-Niles Workplace Arrangement Hybrid Overview Seeking a Specialist II, Product Management with Audio Insight and Sustainability Savvy Join us to...


  • Niles, Illinois, United States Arch Dental Full time

    Arch Dental Seeks Clinical SupportThe role of a Dental Assistant is crucial in providing high-quality oral health care. As part of our team, you will work closely with dentists and staff to ensure seamless patient care.This position requires a skilled individual who values teamwork and delivering exceptional patient care. Our team members are held to a high...