Senior Quality Engineer

Overview

Role involves ensuring quality and compliance in a regulated medical device environment.

Ideal candidate should have 6-8 years of experience in quality engineering within the medical device industry.

Locations

• United States

Requirements

• 6-8 years of experience in medical device industry
• Strong knowledge of ISO 13485, ISO 14971, and 21 CFR 820
• Experience with Software as a Medical Device (SaMD)

Responsibilities

• Lead quality support for software releases
• Manage internal and external audits
• Collaborate with regulatory agencies
• Contribute to risk management processes
• Drive CAPA and non-conformance processes
• Conduct quality impact assessments
• Support and train internal teams

Benefits

• Competitive base salary
• Annual cash bonus and stock options
• Flexible remote work environment
• Health, dental, and vision insurance
• Paid time off and company holidays
• Ongoing training and professional development opportunities
• Inclusive and supportive team culture