Software Quality Assurance Specialist

1 month 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

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