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.

• 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.

• 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.

• 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.

• Contribute to internal audit programs, nonconformance investigations, and CAPA processes as capacity and business needs require.
• Support quality system improvements and QMS maintenance activities in collaboration with the broader Quality team.
• Provide quality engineering input to design control, risk management, and design transfer activities.

• Partner with R&D to review supplier-related design inputs, specifications, and drawing requirements to ensure manufacturability and quality at source.
• Support Manufacturing Operations a in resolving supply chain disruptions, material shortages, and nonconformance events.
• Contribute to product risk assessments and FMEAs with supply chain quality inputs.
• Provide supplier quality input to new product development and design transfer activities.

• Identify and drive continuous improvement initiatives within the supplier base and internal receiving/inspection processes.
• Apply quality tools such as 8D, Fishbone/Ishikawa, 5-Why, FMEA, and SPC to solve supplier quality problems.
• Benchmark supplier quality best practices and recommend enhancements to Zenflow's supplier quality program as the company scales.

• Perform all duties in compliance with Zenflow's QMS and applicable regulatory requirements.

• Travel to supplier sites as required to conduct audits, support qualification activities, or resolve quality issues (estimated 20–30%).

• Bachelor's degree required in Engineering, Materials Science, Biomedical Engineering, or a related technical discipline; advanced degree a plus.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.

• Minimum 5+ of quality engineering experience in the medical device industry, with a primary focus in supplier quality.
• Demonstrated senior-level ownership of supplier quality programs; experience building or significantly improving supplier quality processes strongly preferred.
• Hands-on experience with hardware/electromechanical medical device components and manufacturing processes (e.g., machined parts, molded components, electromechanical assemblies, sterile packaging).
• Demonstrated experience conducting supplier audits (ISO 13485 / FDA QSR) and managing Supplier Corrective Action Requests (SCARs).
• Experience supporting or leading first-product commercialization in a medical device startup or small company environment strongly preferred.
• Proficiency with quality tools including FMEA, SPC, 8D, root cause analysis, and sampling plans.
• Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971 (Risk Management), and applicable standards.
• Exposure to broader quality engineering functions (internal audits, CAPA, nonconformance management) is a plus.
• Experience building or significantly improving a supplier quality program from the ground up, ideally in a small- to mid-size medical device company.
• Proven ability to manage supplier relationships independently, including difficult conversations around performance, corrective actions, and escalations.
• Comfort supporting the broader QMS and contributing to quality functions beyond supplier quality when business needs require it.
• Strong technical writing skills; ability to author clear, audit-ready quality documentation (SOPs, work instructions, qualification reports).
• Proficiency with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva Vault, or similar) and standard office/data tools.
• Excellent verbal and written skills, with the ability to convey complex quality issues in clear, concise terms.

• Self-directed, detail-oriented, and highly organized.
• Proactive ownership mindset, with the ability to identify problems early, develop practical solutions, and drives issues to closure.
• Collaborative team player who works well in a small, cross-functional team; able and willing to flex into broader quality responsibilities as the business requires.
• High integrity and commitment to patient safety as the ultimate driver of all quality decisions.