Quality Engineer
Ampa•Palo Alto, CA
•Onsite
About The Position
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.
Requirements
- 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.
- Bachelor’s degree preferably in engineering, and 0-2+ years in medical device quality engineering/regulatory affairs.
Responsibilities
- Ensure FDA and global compliance, manage registration, and maintain documentation.
- Oversee CAPAs, audits, and supplier quality, driving continuous improvement.
- Manage complaints, adverse events, and non-conformances with proper documentation and reporting.
- Conduct post-market surveillance, update risk files, and assess regulatory impact of changes.
- Prepare for and host ISO 13485/MDSAP audits, ensuring audit readiness.
Benefits
- Substantial equity as an early team member.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1-10 employees
