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Senior Software Quality Assurance Specialist

2 months ago

Irvine, California, United States Glidewell Full time

Software Quality Assurance Leadership Role

Overview:

The position entails overseeing the establishment of a Software Quality Management System that adheres to FDA Quality System Regulations and ISO 13485 Design Controls.

Key Responsibilities:

  • Directs the deployment of the Quality Management System software.
  • Partners with software engineering teams to develop Design History Files.
  • Conducts thorough investigations and formulates corrective measures.
  • Incorporates risk management and usability engineering practices.
  • Guides software development teams in adhering to design controls.
  • Ensures the organization meets compliance standards within the quality system.
  • Offers assistance for CAPA, complaints, and software-related audits.

Qualifications:

  • Bachelor's degree in Computer Science or a related discipline.
  • A minimum of 8 years in software design assurance within the medical device sector.
  • Familiarity with Agile software development methodologies.
  • Prior experience with digital health solutions or mobile medical applications.

Skills and Expertise:

  • In-depth understanding of software development standards.
  • Knowledge of regulatory frameworks for software applications.
  • Capability to implement and enhance Software QMS processes.
  • Familiarity with automated testing frameworks and AWS architecture.
  • Proven time-management abilities and meticulous attention to detail.
  • Excellent teamwork and communication skills.

Company Profile:

Glidewell Laboratories stands at the forefront of dental technology, recognized for its commitment to innovation and quality. The organization is dedicated to delivering accessible dental solutions on a global scale.