What are the responsibilities and job description for the Quality Engineer position at Ampa?
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.
What To Expect
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. Success here requires resilience, adaptability, and the discipline to put in long hours. If you thrive in a high-intensity, fast-changing environment and want your work to truly matter, you may do the best work of your life here.
Role Overview
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.
Key Responsibilities
Generally
What To Expect
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. Success here requires resilience, adaptability, and the discipline to put in long hours. If you thrive in a high-intensity, fast-changing environment and want your work to truly matter, you may do the best work of your life here.
Role Overview
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.
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.
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.
- 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.
- 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.
- 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.
Salary : $90,000 - $110,000