Product Complaints Quality Engineer

Noctrix Health•Pleasanton, CA

10h•$80,000 - $130,000•Hybrid

About The Position

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. Our growing company is looking for a Product Complaints Quality Engineer. In this role the candidate will lead the Noctrix product complaint process. They will facilitate complaint investigations with multiple groups, follow up with the Noctrix Therapy Support Specialists, close the complaints and lead weekly complaint meetings. This data is used for trend analysis to implement process or product improvements enhancing the customer experience. This position also participates in FDA, ISO 13485, and EU MDR audits to ensure complaint processes meet all regulatory requirements. This position reports to the QA Director. This is a full-time, hybrid role based in Pleasanton, CA (at least 4 in-office days per week, or more depending on business needs).

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

Nice To Haves

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

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