Senior Product Quality Assurance Engineer (Hybrid)

The Senior Product Quality Assurance Engineer is responsible for ensuring new and sustaining products meet quality and safety standards, regulatory requirements, and user needs. They specialize in design controls and provide strategic business technical support around QA systems and processes.

Requirements

• Bachelor's degree in engineering
• Minimum of 5 years of experience
• Advanced knowledge of FDA design controls
• Experience with digital health software applications
• Basic to intermediate understanding of Artificial Intelligence tools
• Experience with conducting internal and external audits
• Experience leading/supporting CAPAs, NCRs and Issue Impact Assessments

Benefits

• Comprehensive medical insurance
• Vision insurance
• Dental insurance
• Life insurance
• AD&D insurance
• Short-term and long-term disability insurance
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Commuter benefits
• 401(k)
• Employee Stock Purchase Plan (ESPP)
• Employee Assistance Program (EAP)
• Tuition assistance
• Paid Time Off (PTO)
• 11 paid holidays
• 3 floating days
• 14 weeks of primary caregiver leave
• 2 weeks of secondary caregiver leave