{"id":3789208,"url":"https://alion.io/job/zenflow-senior-quality-supplier-engineer-zenflow","title":"Senior Quality Supplier Engineer - Zenflow","company":{"id":3777180,"name":"Zenflow","domain":"zenflow.com","url":"https://alion.io/company/zenflow","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":120000,"max":135000,"currency":"USD","period":"year","gross":null,"usd_annual":135000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"FMEA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Statistical Process Control","optional":false},{"name":"Veeva","optional":true}],"status":"live","first_seen_at":"2026-11-05T05:31:31Z","employer_posted_date":"2026-11-05","last_verified_at":"2026-11-10T07:34:44Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"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.\nPURPOSE OF JOB: The Senior Quality Engineer is responsible for establishing, managing, and continuously improving the supplier quality program as the company commercializes its first product. While supplier quality is the core focus of this role, the Sr. QE is expected to contribute to the broader quality function as needed, including support for internal audits, CAPA, nonconformance management, and quality system improvements. This role ensures that all components, sub-assemblies, and materials sourced from external suppliers consistently meet Zenflow's quality, safety, and regulatory requirements. The Sr. QE works cross-functionally with R&D, Manufacturing Operations, and Regulatory to qualify new suppliers, manage supplier performance, and drive resolution of supply chain quality issues. This role is expected to operate with a high degree of independence and ownership, helping to build scalable supplier quality systems that will support Zenflow's next-generation product pipeline.\nMAJOR DUTIES AND RESPONSIBILITIES:\nSupplier Qualification & Onboarding\nLead the qualification of new suppliers, including the development and execution of Supplier Qualification Plans (SQPs) and associated audits.\nEvaluate supplier quality systems, manufacturing capabilities, and risk profiles through desk assessments, on-site audits, and technical reviews.\nManage Approved Supplier List (ASL) maintenance and ensure supplier files are complete, current, and compliant with QMS requirements.\nCollaborate with Procurement and R&D to identify, evaluate, and qualify suppliers for new product introductions and design changes.\n Incoming Quality & InspectionDevelop, implement, and maintain Incoming Quality Control (IQC) processes, inspection plans, and acceptance criteria for purchased components and materials.\nReview and approve First Article Inspection Reports (FAIRs), Certificates of Conformance (CoC), and material/dimensional data packages.\nDrive resolution of incoming inspection failures and nonconforming material with suppliers in a timely and documented manner.\nSupport the implementation and validation of statistical sampling plans (e.g., ANSI/ASQ Z1.4, Z1.9) appropriate for a commercial-stage medical device company.\n Supplier Performance ManagementEstablish and maintain supplier scorecards and Key Performance Indicators (KPIs) including quality, delivery, and responsiveness metrics.\nLead Supplier Corrective Action Request (SCAR) processes; work directly with suppliers to ensure timely, effective root cause analysis and corrective/preventive actions (CAPA).\nConduct periodic supplier performance reviews and communicate findings to internal stakeholders.\nEscalate chronic supplier performance issues and recommend re-qualification, resource changes, or supplier transitions as appropriate.\n Quality System & Regulatory ComplianceEnsure all supplier quality activities are performed in compliance with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and applicable international standards.\nAuthor, review, and maintain supplier quality SOPs, work instructions, and quality records within the Zenflow Quality Management System (QMS).\nSupport internal and external audits (FDA inspections, Notified Body audits) with supplier quality documentation and evidence.\nParticipate in Management Review and Quality meetings as a supplier quality subject matter expert.\nBroader Quality Function SupportContribute to internal audit programs, nonconformance investigations, and CAPA processes as capacity and business needs require.\nSupport quality system improvements and QMS maintenance activities in collaboration with the broader Quality team.\nProvide quality engineering input to design control, risk management, and design transfer activities.\nCross-Functional CollaborationPartner with R&D to review supplier-related design inputs, specifications, and drawing requirements to ensure manufacturability and quality at source.\nSupport Manufacturing Operations a in resolving supply chain disruptions, material shortages, and nonconformance events.\nContribute to product risk assessments and FMEAs with supply chain quality inputs.\nProvide supplier quality input to new product development and design transfer activities.\nContinuous ImprovementIdentify and drive continuous improvement initiatives within the supplier base and internal receiving/inspection processes.\nApply quality tools such as 8D, Fishbone/Ishikawa, 5-Why, FMEA, and SPC to solve supplier quality problems.\nBenchmark supplier quality best practices and recommend enhancements to Zenflow's supplier quality program as the company scales.\n GeneralPerform all duties in compliance with Zenflow's QMS and applicable regulatory requirements.\nTravel to supplier sites as required to conduct audits, support qualification activities, or resolve quality issues (estimated 20-30%).\nEDUCATION / EXPERIENCE REQUIREMENTS: \nBachelor's degree required in Engineering, Materials Science, Biomedical Engineering, or a related technical discipline; advanced degree a plus.\nASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.\nEXPERIENCE REQUIREMENTS:\nMinimum 5+ of quality engineering experience in the medical device industry, with a primary focus in supplier quality.\nDemonstrated senior-level ownership of supplier quality programs; experience building or significantly improving supplier quality processes strongly preferred.\nHands-on experience with hardware/electromechanical medical device components and manufacturing processes (e.g., machined parts, molded components, electromechanical assemblies, sterile packaging).\nDemonstrated experience conducting supplier audits (ISO 13485 / FDA QSR) and managing Supplier Corrective Action Requests (SCARs).\nExperience supporting or leading first-product commercialization in a medical device startup or small company environment strongly preferred.\nProficiency with quality tools including FMEA, SPC, 8D, root cause analysis, and sampling plans.\nFamiliarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and applicable standards.\nExposure to broader quality engineering functions (internal audits, CAPA, nonconformance management) is a plus.\nExperience building or significantly improving a supplier quality program from the ground up, ideally in a small- to mid-size medical device company.\nProven ability to manage supplier relationships independently, including difficult conversations around performance, corrective actions, and escalations.\nComfort supporting the broader QMS and contributing to quality functions beyond supplier quality when business needs require it.\nStrong technical writing skills; ability to author clear, audit-ready quality documentation (SOPs, work instructions, qualification reports).\nProficiency with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva Vault, or similar) and standard office/data tools.\nExcellent verbal and written skills, with the ability to convey complex quality issues in clear, concise terms.\nOTHER QUALIFICATIONS: \nSelf-directed, detail-oriented, and highly organized.\nProactive ownership mindset, with the ability to identify problems early, develop practical solutions, and drives issues to closure.\nCollaborative team player who works well in a small, cross-functional team; able and willing to flex into broader quality responsibilities as the business requires.\nHigh integrity and commitment to patient safety as the ultimate driver of all quality decisions.\nThis position is based in South San Francisco, CA. The expected salary range for this position is $120,000-$135,000, 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.","description_format":"text","description_chars":8361,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Health & Medical Electronics"],"lifecycle":[{"event":"open","at":"2026-11-05T05:31:31Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":5,"expected_fill_days":36,"reasons":["conf:5","win:early"],"computed_at":"2026-11-10T06:52:35Z"},"pay":{"stated_usd_annual":135000,"is_top_pay":false},"html_url":"https://alion.io/job/zenflow-senior-quality-supplier-engineer-zenflow","json_url":"https://alion.io/job/zenflow-senior-quality-supplier-engineer-zenflow.json","meta":{"generated_at":"2026-11-10T12:56:08Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":30091,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-11T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3777180},"rest":"https://alion.io/mcp/rest/get_company?id=3777180"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzenflow-senior-quality-supplier-engineer-zenflow"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fzenflow-senior-quality-supplier-engineer-zenflow"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fzenflow-senior-quality-supplier-engineer-zenflow"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/zenflow-senior-quality-supplier-engineer-zenflow\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzenflow-senior-quality-supplier-engineer-zenflow"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3789208}},{"tool":"search_jobs","arguments":{"company":"zenflow.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3789208},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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