Product Complaints Quality Engineer

<p><span data-contrast="auto">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.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="none">Our growing company is looking for a</span><strong><span data-contrast="none"> Product Complaints Quality Engineer</span></strong><span data-contrast="none">. 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. </span><span data-contrast="auto">This position also participates in FDA, ISO 13485, and EU MDR audits to ensure complaint processes meet all regulatory requirements.</span><span data-ccp-props="{}"> </span></p> <p><span data-contrast="auto">This position reports to the </span><strong><span data-contrast="auto">QA Director</span></strong><span data-contrast="auto">. This is a </span><strong><span data-contrast="auto">full-time, hybrid role based in Pleasanton, CA</span></strong><span data-contrast="auto"> (at least 4 in-office days per week, or more depending on business needs).</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></p> <p><strong><span data-contrast="auto">Responsibilities:</span></strong><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></p> <ul> <li><span data-contrast="auto">Receive, evaluate and close product complaints related to Noctrix medical devices</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Data analysis to present trends and analysis to inform product and process improvement initiatives</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Coordinate cross-functional complaint investigations with QA, Regulatory, Engineering, Operations, and Research teams</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Collaborate with Therapy Support to gather customer input and provide updates during complaint resolution</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Prepare and present data, charts, and trend analyses to identify product and process improvement opportunities</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Lead a bi-weekly cross-functional complaints meeting evaluating new complaints</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Serve as the complaint Subject Matter Expert (SME) during internal audits, FDA inspections, and ISO/EU MDR audits</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Ensure complaint data is complete, accurate, legible, and closed in compliance with regulatory standards</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Assist with documentation for FDA and EU MDR reporting</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Support CAPA and NCR activities as needed</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Contribute to continuous improvement initiatives by leveraging complaint data</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Requirements:</span></strong><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></p> <ul> <li><span data-contrast="auto">Bachelor’s degree in Engineering preferred; other life sciences degrees or relevant work experience considered</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">3-5 years of experience in an FDA/ISO regulated environment (medical devices or pharmaceuticals)</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Experience with receiving, reviewing, closing and presenting complaints</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Knowledge of investigative tools such as failure analysis, fishbone diagrams, decision trees, and FMEA</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Strong skills in documentation and proficiency with Excel, Word, and PowerPoint</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Knowledge of ISO standards, FDA regulations, and industry guidelines, including ISO 13485, 21 CFR 820, and 21 CFR Part 11</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Team player with strong attention to detail and interpersonal skills across all levels</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Ability to adapt to changing priorities and work independently on assignments</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Good problem-solving skills</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Ability to lift up to 20 lbs and sit for prolonged periods at a desk working on a computer</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Qualifications:</span></strong><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></p> <ul> <li><span data-contrast="auto">Excellent verbal and written communication skills</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Strong organizational and time management abilities</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Effective leadership skills to guide cross-functional meetings</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> <li><span data-contrast="auto">Sound judgment with the ability to exercise discretion in the execution of duties</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> </ul> <p><strong><span data-contrast="auto">Compensation:</span></strong><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></p> <ul> <li data-leveltext="●" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"●","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Base pay: $80,000–$130,000 per year + bonus + stock options</span><span data-ccp-props="{"335559738":240,"335559739":240}"> </span></li> </ul>