Quality Engineer
Ampa
Quality Engineer
Ampa
Posted 2 months ago
Full Time
Palo Alto, California
In Person
Smart Summary
Responsibilities
The Quality Engineer will oversee regulatory compliance, internal audits, and CAPA management for neurostimulation systems. They are also responsible for managing complaints, post-market surveillance, and ensuring readiness for ISO 13485 and MDSAP audits.
Qualifications
You have a Bachelor's degree, preferably in engineering, and 0-2+ years of experience in medical device quality engineering or regulatory affairs. You are meticulous and possess strong attention to detail for maintaining records, managing audits, and ensuring compliance with regulatory standards.
Must Have Skills for ATS
FDA
CAPA
ISO 13485
MDSAP
medical device quality engineering
regulatory affairs
Job Description
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.
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 0-2+ 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: $90K-110K + Strong Equity
- Employment Type: Permanent
- Visa Sponsorship: Will sponsor TN visa or equivalent. No H1B.
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