Aircraft Troubleshooting Engineer – Mid-level/Senior
Boeing
Product Complaints Engineer
Noctrix Health, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Pleasanton • California • 🇺🇸 United States
Visit company websiteSalary
💰 $70,000 - $85,000 per year
Job Level
JuniorMid-Level
About the role
- Receive and evaluate product complaints related to Noctrix medical devices
- Coordinate cross-functional complaint investigations with QA, Engineering, Operations, and Research teams
- Collaborate with Therapy Support to gather customer input and provide updates during complaint resolution
- Prepare and present data, charts, and trend analyses to identify product and process improvement opportunities
- Lead bi-weekly cross-functional complaint review meetings
- Serve as the complaint Subject Matter Expert (SME) during internal audits, FDA inspections, and ISO/EU MDR audits
- Ensure complaint data is complete, accurate, legible, and closed in compliance with regulatory standards
- Assist with documentation for FDA and EU MDR reporting
- Support CAPA and NCR activities as needed
- Contribute to continuous improvement initiatives by leveraging complaint data
Requirements
- Bachelor’s degree in Engineering preferred; other life sciences degrees or relevant work experience considered
- 2 to 4 years of experience in an FDA/ISO regulated environment (medical devices or pharmaceuticals)
- Knowledge of investigative tools such as failure analysis, fishbone diagrams, decision trees, and FMEA
- Strong skills in documentation and proficiency with Excel, Word, and PowerPoint
- Knowledge of ISO standards, FDA regulations, and industry guidelines, including ISO 13485, 21 CFR 820, and 21 CFR Part 11
- Team player with strong attention to detail and interpersonal skills across all levels
- Ability to adapt to changing priorities and work independently on assignments
- Good problem-solving skills
- Ability to lift up to 20 lbs and sit for prolonged periods at a desk working on a computer.
Benefits
- bonuses
- stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
failure analysisfishbone diagramsdecision treesFMEAdocumentationExcelWordPowerPoint
Soft skills
attention to detailinterpersonal skillsproblem-solvingadaptabilityindependence
Certifications
Bachelor’s degree in EngineeringISO 1348521 CFR 82021 CFR Part 11
