Disclaimer: Working at Ampa is a rare chance to help transform global mental health and save millions of lives — a level of impact that demands deep commitment. Our team puts in 60–80 hours per week because the Mission calls for it, and we relish the chance to do work this meaningful. It’s not for most people :)
Role Overview:
We seek 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.
Key Responsibilities:
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.
What We’re Looking For:
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 3+ years in medical device quality engineering/regulatory affairs.
Why Join Ampa?
Impact: Lead the development of transformative mental health technologies.
Growth: Thrive in a startup environment with rapid innovation.
Stability: Enjoy startup benefits with a secure product line.
Ownership: Receive substantial equity as an early team member.
Logistics:
Work Mode: In-person
Location: Palo Alto, CA
Compensation: $80K to $120K · 0.2% - 0.4% Equity
Employment Type: Permanent
Visa Sponsorship: Will sponsor TN visa or equivalent. No H1B.