Founding Quality Engineer
Job Title: Founding Quality Engineer
Disclaimer: This role has the potential to save millions of lives and requires an intense commitment of 60-80 hours per week over many years. It’s a challenging role that's not suitable for most people.
Ampa is a leading neurotechnology startup developing noninvasive brain stimulators to help eradicate depression. Our mission is to make this transformative treatment universally accessible and improve the lives of millions. As a rapidly growing startup, joining us now offers the opportunity to receive a significant equity package and play a key role in shaping our future direction.
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:
- Driven and Talented: Highly motivated, with a good feedback loop. Missing skills can be learned.
- Attention to Detail: Precision in maintaining records, managing audits, and ensuring compliance with regulatory standards.
- Experience: Bachelor’s degree preferably in engineering, and 1+ year in medical device quality engineering/regulatory affairs. Willingness to learn from top consultants.
- Problem-Solving: Capable of navigating complex regulatory challenges and implementing effective solutions.
- Adaptability: Thrive in a fast, dynamic startup environment.
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
- Locations: Bay Area, San Diego, or Remote with monthly travel.
- Compensation: $80K to $120K · 0.4% - 0.8% Equity
- Employment Type: Permanent
- Visa Sponsorship: Not available
To Apply:
Send your materials to recruiting@ampahealth.com