Product Complaints Quality Engineer
Noctrix Health, Inc.
full-time
Posted on:
Location Type: Hybrid
Location: Pleasanton • California • 🇺🇸 United States
Visit company websiteSalary
💰 $80,000 - $130,000 per year
Job Level
Mid-LevelSenior
About the role
- Receive, evaluate and close product complaints related to Noctrix medical devices
- Data analysis to present trends and analysis to inform product and process improvement initiatives
- Coordinate cross-functional complaint investigations with QA, Regulatory, 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 a bi-weekly cross-functional complaints meeting evaluating new complaints
- 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
- 3-5 years of experience in an FDA/ISO regulated environment (medical devices or pharmaceuticals)
- Experience with receiving, reviewing, closing and presenting complaints
- 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
- Base pay: $80,000–$130,000 per year + bonus + stock options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
data analysiscomplaint resolutioninvestigative toolsfailure analysisfishbone diagramsdecision treesFMEAdocumentationExcelWord
Soft skills
attention to detailinterpersonal skillsproblem-solvingadaptabilityteam player