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Quality Engineer I

Pleasanton, CA

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. 

We are seeking a motivated and detail-oriented Quality Engineer I to support Noctrix Health’s product complaint investigation and post-market surveillance processes for our therapeutic wearable technologies designed to treat Restless Legs Syndrome. In this role, you will work cross-functionally with Engineering, Quality, Operations, and R&D teams to investigate product complaints, document findings, and support timely complaint closure activities in compliance with medical device quality standards.

This role offers an excellent opportunity for an early-career engineer or life sciences professional to develop within a rapidly growing medical device company focused on improving patient outcomes and advancing wearable neurostimulation technologies. The Quality Engineer I will contribute directly to product quality improvements, regulatory compliance, and enhancement of the customer experience through effective investigation and trending activities.

This is a full-time, onsite position located in our Pleasanton, CA office.

Responsibilities:

  • Support Noctrix’s product complaint handling and post-market surveillance processes, ensuring timely investigation, documentation, and closure of medical device complaints in accordance with internal procedures and regulatory requirements
  • Assist with receiving, inspecting, and performing physical and functional testing on returned customer medical devices using a variety of test equipment
  • Collaborate cross-functionally with Research & Development, Engineering, Operations, and Quality teams to support root cause investigations and document findings
  • Record and maintain complaint data within the company complaint management system following Good Documentation Practices (GDP)
  • Provide supporting data and inputs for recurring cross-functional Complaint Review Meetings
  • Assist with preparation of charts, graphs, and trending reports related to complaint data and post-market surveillance metrics
  • Support Quality Assurance and Post-Market teams with complaint closure activities and non-routine product investigations
  • Support preparation of quality and complaint-related documentation for internal and external regulatory audits
  • Contribute to continuous improvement initiatives related to complaint handling processes, product quality, and operational efficiency
  • Support departmental goals related to complaint turnaround time, data accuracy, and quality system compliance
  • Provide additional support within the Quality Assurance department as needed

Requirements:

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline
  • Recent graduate or up to approximately 2 years of industry experience, including internships or co-op experience, preferably within the medical device industry
  • Exposure to problem-solving methodologies and investigative techniques through academic or industry experience
  • Basic understanding of FDA regulations, ISO standards, and medical device quality systems preferred
  • Strong written and verbal communication skills with attention to detail and documentation quality
  • Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint
  • Ability to learn and effectively use collaboration and communication tools such as Teams and related platforms
  • Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment
  • Ability to work both independently and collaboratively within cross-functional teams
  • Strong analytical thinking and problem-solving capabilities

Physical Requirements:

  • Ability to lift up to 20 pounds as needed
  • Ability to sit for extended periods while working at a computer and performing documentation activities

Preferred Qualifications:

  • Internship, co-op, or industry experience within a regulated medical device or healthcare environment
  • Experience or coursework related to root cause analysis, failure investigation, or quality systems
  • Familiarity with complaint handling, post-market surveillance, CAPA, or related quality processes
  • Experience working with electronic or wearable medical devices
  • Interest in quality engineering and long-term career growth within the medical device industry

Compensation:

  • Base pay: $80,000 - $120,000 + bonus

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