Quality Engineer

Ampa is a pioneering neurotechnology startup developing brain stimulation technology to help eradicate depression. We will improve millions of lives by making this transformative treatment universally accessible. Joining us means you’ll be part of a rapidly growing startup with significant equity opportunities and a major impact on our future.

Ampa is seeking a meticulous Quality Engineer to ensure regulatory compliance and uphold the highest quality standards for our neurostimulation systems. In this critical role, you will oversee all aspects of quality management, including internal audits, CAPA management, supplier quality, post-market surveillance, and compliance with FDA and global regulations.

• →Regulatory Compliance: Ensure FDA and global compliance, manage registration, and maintain documentation.
• →CAPA & Quality: Oversee CAPAs, audits, and supplier quality, driving continuous improvement.
• →Complaint Handling: Manage complaints, adverse events, and non-conformances with proper documentation and reporting.
• →Surveillance & Risk: Conduct post-market surveillance, update risk files, and assess regulatory impact of changes.
• →Audit Management: Prepare for and host ISO 13485/MDSAP audits, ensuring audit readiness.

Generally

• Mission Obsession: You’re passionate about eradicating depression.
• Drive: Highly motivated, open to feedback, and able to learn new skills as needed.
• Adaptability: Thrives in a fast-paced, evolving startup.

Specific to this role

• Attention to Detail: Precision in maintaining records, managing audits, and ensuring compliance with regulatory standards.
• Experience: Bachelor’s degree preferably in engineering, and 0-2+ years in medical device quality engineering/regulatory affairs.

• Work Mode: In-person
• Location: Palo Alto, CA
• Compensation: $90K-110K + Strong Equity
• Employment Type: Permanent
• Visa Sponsorship: Will sponsor TN visa or equivalent. No H1B.