Product Complaints Quality Engineer

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).

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
  
  

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