Senior Quality Engineer

<p><b>About Zenflow</b><br><a href="http://www.zenflow.com/" title="http://www.zenflow.com/">Zenflow, Inc.</a>&#160;is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring&#174; technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props&#160;open the&#160;urethra, restoring its normal function while preserving the natural anatomy.&#160;The Zenflow Spring System is now FDA approved for commercial sale.<br><br><strong>PURPOSE OF JOB:</strong></p><p>We are a dynamic medical device start-up seeking a highly skilled and motivated Senior Quality Engineer to join our team. The ideal candidate will play a crucial role in ensuring our products meet the highest standards of quality and regulatory compliance. This position involves working closely with cross-functional teams to support product development, manufacturing, post-market, and overall quality system activities.</p><p><strong>MAJOR DUTIES AND RESPONSIBILITIES:</strong></p><p><strong>Product Development Support:</strong></p><ul><li>Participate in new and modified product development projects.</li><li>Establish product specifications and support manufacturing process validation.</li><li>Develop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ).</li><li>Conduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA.</li></ul><p><strong>Quality Management System (QMS):</strong></p><ul><li>Maintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements.</li><li>Conduct internal and supplier audits to ensure compliance with quality standards.</li><li>Support external regulatory body audits and inspections.</li></ul><p><strong>Non-Conformance and CAPA:</strong></p><ul><li>Investigate and resolve non-conformances and product complaints.</li><li>Lead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate.</li><li>Track and analyze quality metrics to monitor processes and identify trends and areas for improvement.</li></ul><p><strong>Supplier Quality Management:</strong></p><ul><li>Qualify new suppliers and manage supplier performance.</li><li>Conduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions.</li></ul><p><strong>Post-Market Surveillance:</strong></p><ul><li>Review and maintain post-market surveillance data and files.</li><li>Track and report on product-related non-conformances and complaint status.</li></ul><p><strong>Continuous Improvement:</strong></p><ul><li>Lead and champion continuous improvement.</li><li>Analyze key performance indicators and drive quality improvements.</li></ul><p><strong>EDUCATION/EXPERIENCE REQUIREMENTS:</strong></p><ul><li>Bachelor&#8217;s or Master&#8217;s degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience.</li><li>Minimum of 5 years of experience in quality engineering, R&amp;D, or manufacturing within the medical device or MedTech industries, or other appropriate technical experience.</li><li>Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.</li><li>In-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations.</li><li>Hands-on experience with Design Verification and Validation (V&amp;V) test plan development, test method validation, execution, and report review.</li><li>Proficiency in risk management tools such as FMEA and root cause analysis.</li><li>Strong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis.</li><li>Excellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment.</li><li>Experience with Lean Manufacturing tools and techniques is an advantage.</li><li>Experience with collecting, analyzing, and presenting quality system performance data for Management Reviews a plus.</li><li>Familiarity with international regulatory requirements (e.g., MDR, TGA, PMDA) a plus.</li><li>Experience with electronic Quality Management Systems (eQMS) preferred.</li><li>Proven track record of successful project management and leadership in a quality engineering role.</li><li>Ability to work independently and balance multiple priorities in a fast-paced, FDA regulated environment.</li><li>Strong verbal and written communication skills.</li><li>Strong organizational and planning skills, with an attention to detail.</li></ul>This position is based in South San Francisco, CA. The expected salary range for this position is $100,000-$130,000, plus comprehensive benefits and equity. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.