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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:

We are seeking a highly skilled professional to oversee the Software Quality Management System, ensuring adherence to FDA Quality System Regulations and ISO 13485 Design Controls.

Key Responsibilities:

  • Direct the establishment and maintenance of the Software Quality Management System.
  • Manage the QMS software administration effectively.
  • Work closely with software development teams to compile Design History Files.
  • Conduct thorough investigations and implement corrective measures.
  • Incorporate risk management and usability engineering practices into the workflow.
  • Provide mentorship to software development teams regarding design controls.
  • Guarantee compliance with the quality system across the organization.
  • Support CAPA, complaints, and audits associated with software.

Qualifications:

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

Essential Skills:

  • In-depth knowledge of software development standards.
  • Understanding of regulatory requirements pertinent to software applications.
  • Capability to implement and enhance Software QMS processes.
  • Knowledge of automated testing frameworks and AWS architecture.
  • Proven time-management abilities and meticulous attention to detail.
  • Strong collaborative and communication skills.

Company Overview:

Glidewell Laboratories is a premier dental technology organization recognized for its commitment to innovation and quality. We are dedicated to delivering cost-effective dental solutions globally.