Lead Supplier Quality Engineer – Controls & Accessories
GE Aerospace
Staff SW Quality Assurance Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $104,325 - $156,487 per year
Job Level
Lead
Tech Stack
Cyber Security
About the role
- Lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle
- Ensure compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements
- Provide guidance for the generation, review, and approval of design control documentation
- Develop and deliver Design Control training for the software development organization
Requirements
- BS degree in computer science, computer engineering or equivalent field
- Master’s degree preferred
- A minimum of 8 years work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485
- Experience with medical device software development
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality AssuranceQuality EngineeringSoftware Development LifecycleDesign ControlCybersecurity Risk ManagementIEC 62304FDA GuidanceISO 13485FDA 21 CFR Part 820Medical Device Software Development
