Senior Quality Supplier Engineer

About Zenflow Zenflow, 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. PURPOSE 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. MAJOR DUTIES AND RESPONSIBILITIES : Supplier Qualification & Onboarding Lead the qualification of new suppliers, including the development and execution of Supplier Qualification Plans (SQPs) and associated audits. Evaluate supplier quality systems, manufacturing capabilities, and risk profiles through desk assessments, on-site audits, and technical reviews. Manage Approved Supplier List (ASL) maintenance and ensure supplier files are complete, current, and compliant with QMS requirements. Collaborate with Procurement and R&D to identify, evaluate, and qualify suppliers for new product introductions and design changes. Incoming Quality & Inspection Develop, implement, and maintain Incoming Quality Control (IQC) processes, inspection plans, and acceptance criteria for purchased components and materials. Review and approve First Article Inspection Reports (FAIRs), Certificates of Conformance (CoC), and material/dimensional data packages. Drive resolution of incoming inspection failures and nonconforming material with suppliers in a timely and documented manner. Support the implementation and validation of statistical sampling plans (e.g., ANSI/ASQ Z1.4, Z1.9) appropriate for a commercial-stage medical device company. Supplier Performance Management Establish and maintain supplier scorecards and Key Performance Indicators (KPIs) including quality, delivery, and responsiveness metrics. Lead Supplier Corrective Action Request (SCAR) processes; work directly with suppliers to ensure timely, effective root cause analysis and corrective/preventive actions (CAPA). Conduct periodic supplier performance reviews and communicate findings to internal stakeholders. Escalate chronic supplier performance issues and recommend re-qualification, resource changes, or supplier transitions as appropriate. Quality System & Regulatory Compliance Ensure all supplier quality activities are performed in compliance with FDA 21 CFR Part 820 (Quality System Regulation), ISO 13485, and applicable international standards. Author, review, and maintain supplier quality SOPs, work instructions, and quality records within the Zenflow Quality Management System (QMS). Support internal and external audits (FDA inspections, Notified Body audits) with supplier quality documentation and evidence. Participate in Management Review and Quality meetings as a supplier quality subject matter expert. Broader Quality Function Support Contribute to internal audit programs, nonconformance investigations, and CAPA processes as capa…

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