Software Quality Assurance Specialist

4 days ago


Niles, Illinois, United States ACL Digital Full time
The Opportunity

We are seeking a highly skilled Software Quality Assurance Specialist to join our team at ACL Digital. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and regulatory compliance of our software products.

Key Responsibilities
  • Develop, implement, and maintain quality assurance processes and procedures to ensure compliance with relevant regulations and industry standards.
  • Work closely with cross-functional teams, including engineering and quality teams, to drive quality excellence and ensure timely resolution of nonconformances.
  • Lead and participate in root cause investigations, risk assessments, and corrective and preventive actions to identify and mitigate risks.
  • Develop and maintain comprehensive procedures, work instructions, and documentation to ensure process compliance and quality excellence.
  • Collaborate with engineering teams to drive quality excellence of digital medical devices, including design reviews, process simplification, and quality system training.
  • Support continuous product and process improvement through detailed failure analysis and investigation of nonconformances.
Qualifications
  • Bachelor's degree in Science, Engineering, or related discipline.
  • 6+ years of related experience, including 3+ years in software quality assurance and validation.
  • Working knowledge of regional and international quality system requirements, including IEC 62304, ISO 14971, FDA 21 CFR 820, and ISO 13485.
  • Experience performing internal audits and participating in external audits.
  • Attention to detail and effective verbal and written communication skills.


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