Source Job

Global

  • Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR.
  • Provide clear, structured audit documentation and evidence-based conclusions.
  • Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values.

ISO 13485

3 jobs similar to Lead Auditor

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$56,532–$88,740/yr
Europe

  • Ensure the quality and regulatory compliance of AI-powered SaMD products.
  • Collaborate with cross-functional teams, including software development, regulatory affairs, and quality assurance.
  • Maintain and review audit-ready evidence for software/AI development.

Sword Health is an AI health company that provides care programs for multiple conditions, from musculoskeletal, to women’s health, to mental health.

US Unlimited PTO

  • Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
  • Own the quality approval process for software components, including documentation review and final release approvals.
  • Partner with the software engineering team to implement and maintain a robust software quality management system.

Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.

$129,600–$286,500/yr
US

  • Drive execution of NPI strategy to develop scalable, high-yield processes.
  • Optimize inspection strategies through technology, automation, and supplier certification.
  • Coach and develop a team of quality engineers to meet performance metrics.

Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!