Quality Systems Specialist

Responsibilities

• Support monitoring and continuous improvement of Quality Management System processes
• Collaborate with Engineering, Manufacturing, and Quality teams on quality process development
• Support internal and external audit preparation and execution
• Monitor and trend QMS nonconformances and quality data
• Drive training activities and tracking to ensure regulatory compliance
• Assist with generation, analysis, and presentation of quality metrics
• Support the CAPA program, including coaching owners and driving investigations
• Support document control activities including review, approval, and change management
• Track and assess new or revised external standards and regulatory requirements

Requirements

• Bachelor’s degree in engineering, medical, science, or equivalent experience
• Minimum of 3 years of experience supporting quality systems in a regulated environment
• Prior experience in the medical device field is required
• Experience with disposable and capital equipment medical devices preferred
• Fluent in English (written and verbal)

Preferred Qualifications

• Lead Auditor Certification
• Certification or training in Lean Six Sigma

About the Company

Outset Medical is a trailblazing medical device company revolutionizing the field of dialysis through groundbreaking technology designed to reduce cost and complexity for patients and providers.