{"schemaVersion":"jobsearcher.job.v1","id":"26ec0ea2b2659e944f49a9ff","url":"https://jobsearcher.com/jobs/26ec0ea2b2659e944f49a9ff","canonicalUrl":"https://jobsearcher.com/jobs/26ec0ea2b2659e944f49a9ff","title":"Senior Quality Engineer","description":"About Zenflow\nZenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is now FDA approved for commercial sale.\n\nPURPOSE OF JOB:\nWe 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.\nMAJOR DUTIES AND RESPONSIBILITIES:\nProduct Development Support:\nParticipate in new and modified product development projects.\nEstablish product specifications and support manufacturing process validation.\nDevelop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ).\nConduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA.\nQuality Management System (QMS):\nMaintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements.\nConduct internal and supplier audits to ensure compliance with quality standards.\nSupport external regulatory body audits and inspections.\nNon-Conformance and CAPA:\nInvestigate and resolve non-conformances and product complaints.\nLead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate.\nTrack and analyze quality metrics to monitor processes and identify trends and areas for improvement.\nSupplier Quality Management:\nQualify new suppliers and manage supplier performance.\nConduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions.\nPost-Market Surveillance:\nReview and maintain post-market surveillance data and files.\nTrack and report on product-related non-conformances and complaint status.\nContinuous Improvement:\nLead and champion continuous improvement.\nAnalyze key performance indicators and drive quality improvements.\nEDUCATION/EXPERIENCE REQUIREMENTS:\nBachelor’s or Master’s degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience.\nMinimum of 5 years of experience in quality engineering, R&D, or manufacturing within the medical device or MedTech industries, or other appropriate technical experience.\nCertified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.\nIn-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations.\nHands-on experience with Design Verification and Validation (V&V) test plan development, test method validation, execution, and report review.\nProficiency in risk management tools such as FMEA and root cause analysis.\nStrong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis.\nExcellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment.\nExperience with Lean Manufacturing tools and techniques is an advantage.\nExperience with collecting, analyzing, and presenting quality system performance data for Management Reviews a plus.\nFamiliarity with international regulatory requirements (e.g., MDR, TGA, PMDA) a plus.\nExperience with electronic Quality Management Systems (eQMS) preferred.\nProven track record of successful project management and leadership in a quality engineering role.\nAbility to work independently and balance multiple priorities in a fast-paced, FDA regulated environment.\nStrong verbal and written communication skills.\nStrong organizational and planning skills, with an attention to detail.\nThis 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.\nKA7f2Cyutc","company":"Zenflow","rawCompany":"zenflow","city":"Millbrae","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T17:43:33.374Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality Engineer","description":"About Zenflow\nZenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is now FDA approved for commercial sale.\n\nPURPOSE OF JOB:\nWe 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.\nMAJOR DUTIES AND RESPONSIBILITIES:\nProduct Development Support:\nParticipate in new and modified product development projects.\nEstablish product specifications and support manufacturing process validation.\nDevelop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ).\nConduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA.\nQuality Management System (QMS):\nMaintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements.\nConduct internal and supplier audits to ensure compliance with quality standards.\nSupport external regulatory body audits and inspections.\nNon-Conformance and CAPA:\nInvestigate and resolve non-conformances and product complaints.\nLead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate.\nTrack and analyze quality metrics to monitor processes and identify trends and areas for improvement.\nSupplier Quality Management:\nQualify new suppliers and manage supplier performance.\nConduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions.\nPost-Market Surveillance:\nReview and maintain post-market surveillance data and files.\nTrack and report on product-related non-conformances and complaint status.\nContinuous Improvement:\nLead and champion continuous improvement.\nAnalyze key performance indicators and drive quality improvements.\nEDUCATION/EXPERIENCE REQUIREMENTS:\nBachelor’s or Master’s degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience.\nMinimum of 5 years of experience in quality engineering, R&D, or manufacturing within the medical device or MedTech industries, or other appropriate technical experience.\nCertified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.\nIn-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations.\nHands-on experience with Design Verification and Validation (V&V) test plan development, test method validation, execution, and report review.\nProficiency in risk management tools such as FMEA and root cause analysis.\nStrong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis.\nExcellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment.\nExperience with Lean Manufacturing tools and techniques is an advantage.\nExperience with collecting, analyzing, and presenting quality system performance data for Management Reviews a plus.\nFamiliarity with international regulatory requirements (e.g., MDR, TGA, PMDA) a plus.\nExperience with electronic Quality Management Systems (eQMS) preferred.\nProven track record of successful project management and leadership in a quality engineering role.\nAbility to work independently and balance multiple priorities in a fast-paced, FDA regulated environment.\nStrong verbal and written communication skills.\nStrong organizational and planning skills, with an attention to detail.\nThis 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.\nKA7f2Cyutc","datePosted":"2026-04-12T17:43:33.374Z","dateModified":"2026-04-12T17:43:33.374Z","hiringOrganization":{"@type":"Organization","name":"Zenflow","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Millbrae","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"26ec0ea2b2659e944f49a9ff"},"url":"https://jobsearcher.com/jobs/26ec0ea2b2659e944f49a9ff"}}