Manager of Clinical QA

We are a rapidly growing medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care. As CQA Manager, you'll lead a team and shape our quality vision, driving verification and validation readiness and serving as a patient safety advocate.

Requirements

• Bachelor's degree in science, engineering, biomedical engineering, or equivalent.
• 6+ years of Clinical QA testing experience in an FDA-regulated environment, with demonstrated experience managing and mentoring a CQA team.
• Working knowledge of FDA, MDD/MDR and ISO 13485 regulations, with hands-on experience in documentation and quality processes in a highly regulated setting.

Benefits

• Health Insurance
• Retirement Plan
• Generous Paid Time Off
• Flexible Working Hours