Product Complaints Quality Engineer

Job Overview

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription‑grade therapy with an outstanding user experience. We have pioneered the world's first drug‑free wearable therapy, clinically proven to alleviate symptoms in adults with drug‑resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.

Product Complaints Quality Engineer – full‑time, hybrid role based in Pleasanton, CA (at least 4 in‑office days per week, or more depending on business needs). Reports to the QA Director.

• Receive, evaluate, and close product complaints related to Noctrix medical devices
• Analyze data to present trends and 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

• 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 Power Point
• 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

• Excellent verbal and written communication skills
• Strong organizational and time management abilities
• Effective leadership skills to guide cross‑functional meetings
• Sound judgment with the ability to exercise discretion in the execution of duties

• Base pay: $80,000–$130,000 per year + bonus + stock options

• Mid‑Senior level

• Full‑time

• Quality Assurance

• Technology
• Information and Internet