Noctrix Health, Inc.
Product Complaints Quality Engineer
Noctrix Health, Inc., Pleasanton, California, United States, 94566
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.
Position 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.
Responsibilities
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
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
Qualifications
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
Compensation
Base pay: $80,000–$130,000 per year + bonus + stock options
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Technology
Information and Internet
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Position 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.
Responsibilities
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
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
Qualifications
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
Compensation
Base pay: $80,000–$130,000 per year + bonus + stock options
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Quality Assurance
Industries
Technology
Information and Internet
#J-18808-Ljbffr