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:
We seek a meticulous Quality Engineer to ensure regulatory compliance and uphold the highest quality standards for our neurostimulation systems across manufacturing and post-market operations. In this role, you will collaborate closely with Manufacturing, Regulatory, Service, and external partners. You will own and support key post-market quality processes, including complaint handling, post-market surveillance, servicing and returns processing, supplier quality activities and evaluations, and nonconformance, CAPA, and MDR support, ensuring that field and service data are properly investigated, documented, trended, and fed back into continuous improvement activities. Software quality experience is a plus. Beyond maintaining existing quality processes, this role is expected to proactively identify, propose, and implement improvements that strengthen quality, efficiency, and regulatory compliance across manufacturing and post-market operations.
Key Responsibilities:
- Regulatory Compliance: Ensure FDA and global compliance, manage documentation for design and manufacturing changes, and support regulatory submissions and letters to file.
- Design & Risk Management: Create and manage Document Change Requests (DCRs), conduct risk assessments, and update risk management files in accordance with ISO 14971.
- Software Verification & Validation: Develop and execute software verification and validation protocols and reports to support software updates.
- Manufacturing Support: Collaborate with manufacturing to ensure controlled documentation of processes, provide technical input for process improvements, and verify compliance with design and quality requirements.
- CMO & 3PL Oversight: Review and approve DHRs for devices transferred from the CMO to the 3PL and finished goods shipped from the 3PL to clients, ensuring full traceability and compliance with release procedures.
- Process Improvement: Continuously evaluate and enhance design control, risk management, and production documentation processes to improve product quality, operational efficiency, and regulatory robustness.
- CAPA & Quality: Oversee CAPAs, audits, and supplier quality, driving continuous improvement and alignment with design and quality requirements.
- Complaint Handling: Manage complaints, adverse events, and non-conformances with proper documentation and reporting.
- Surveillance & Risk: Conduct post-market surveillance, trend analysis, and risk file maintenance to ensure ongoing product safety and effectiveness.
- Audit Management: Prepare for and host ISO 13485/MDSAP audits, ensuring audit readiness and robust design documentation.
What We’re Looking For:
Specific to this role
- Experience: 3+ years in medical device R&D, quality engineering, or regulatory affairs, with experience in complaint handling, supplier quality, risk management, software as a medical device (SaMD) and manufacturing process documentation.
- Education: Bachelor’s degree, preferably in Engineering
- Attention to Detail: Precision in managing design documentation, verification protocols, manufacturing records, and regulatory documentation.
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.
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.