ACL Digital
Software Quality Assurance Specialist
ACL Digital, Niles, Illinois, United States, 60714
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 businessWork hands-on with quality and compliance activities around Software Development ProjectsEnsuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibilityDevelops 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 strategyResponsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the siteDevelop process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methodsWork with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etcLead 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, etcDevelop process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management processEnsures 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 discipline6 years of related experience, including 3+ years' experience in Software Quality Assurance and validationWorking knowledge of regional and international quality system requirements including IEC 62304, ISO 14971, FDA 21 CFR 820, ISO 13485, CFR Part 11 for Medical DevicesExperience performing internal audits and participating in external auditsAttention to detailEffective verbal and written communication skills
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 businessWork hands-on with quality and compliance activities around Software Development ProjectsEnsuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibilityDevelops 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 strategyResponsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the siteDevelop process improvement plans using a variety of Quality and Continuous Process Improvement tools, utilizing the Agile/Lean methods and traditional project management methodsWork with engineering teams closely to drive quality excellence of digital medical devices, including design reviews, processes/practices simplification, quality system training, etcLead 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, etcDevelop process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management processEnsures 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 discipline6 years of related experience, including 3+ years' experience in Software Quality Assurance and validationWorking knowledge of regional and international quality system requirements including IEC 62304, ISO 14971, FDA 21 CFR 820, ISO 13485, CFR Part 11 for Medical DevicesExperience performing internal audits and participating in external auditsAttention to detailEffective verbal and written communication skills