Noctrix Health, Inc. · 2 weeks ago
Product Complaints Quality Engineer
Pleasanton, CA (Hybrid)
Full-time
Hybrid
Mid Level
$80K/yr - $130K/yr
3+ years expNoctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. They are seeking a Product Complaints Quality Engineer to lead the product complaint process, facilitate investigations, and ensure compliance with regulatory standards.
Health CareMedical DeviceTherapeutics
Responsibilities
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
Qualification
Required
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
Preferred
Bachelor's degree in Engineering preferred; other life sciences degrees or relevant work experience considered
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
Benefits
Bonus
Stock options
Company
Noctrix Health, Inc.
Noctrix Health is pioneering the next-generation of therapeutic wearables that empower patients to take control of their chronic medical conditions.
11-50 employees
H1B Sponsorship
Noctrix Health, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Growth StageTotal Funding
$90.5MKey Investors
Bridge BankSectoral Asset Management
2025-08-29Series Unknown· $33.5M
2025-08-29Debt Financing
2024-01-16Series C· $40M
Leadership Team
Jonathan Charlesworth
Chief Scientific Officer
Recent News
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