Senior Quality Supplier Engineer

Zenflow•South San Francisco, CA

4d•$120,000 - $135,000•Onsite

About The Position

Zenflow, Inc. is a privately held medical device company focused on improving treatment for urinary obstruction caused by enlarged prostate. Its Spring® technology is designed to gently prop open the urethra while preserving natural anatomy, and the Zenflow Spring System is FDA approved for commercial sale. The Senior Quality Engineer will establish, manage, and continuously improve Zenflow’s supplier quality program as the company commercializes its first product. The role ensures externally sourced components, sub-assemblies, and materials meet quality, safety, and regulatory requirements. Supplier quality is the central focus, with additional contributions to internal audits, CAPA, nonconformance management, and quality system improvements as needed. The position works with R&D, Manufacturing Operations, Regulatory, and Procurement to qualify suppliers, manage performance, and resolve supply chain quality issues. It requires independent ownership and development of scalable systems to support future products. The position is based in South San Francisco, California, and requires travel to supplier sites as needed, estimated at 20–30%. The expected salary range is $120,000–$135,000, plus comprehensive benefits and equity.

Requirements

Bachelor’s degree in Engineering, Materials Science, Biomedical Engineering, or a related technical discipline.
At least 5 years of quality engineering experience in the medical device industry, primarily focused on supplier quality.
Senior-level ownership of supplier quality programs; experience building or substantially improving supplier quality processes.
Hands-on experience with hardware or electromechanical medical device components and manufacturing processes, such as machined parts, molded components, electromechanical assemblies, or sterile packaging.
Experience conducting supplier audits against ISO 13485 and FDA QSR requirements and managing Supplier Corrective Action Requests.
Proficiency with FMEA, SPC, 8D, root cause analysis, and sampling plans.
Familiarity with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable standards.
Ability to independently manage supplier relationships, including performance discussions, corrective actions, and escalations.
Strong technical writing skills and ability to create clear, audit-ready quality documentation, including SOPs, work instructions, and qualification reports.
Proficiency with eQMS platforms and standard office and data tools.
Excellent verbal and written communication skills, including the ability to explain complex quality issues clearly and concisely.
Self-directed, detail-oriented, highly organized, and proactive, with the ability to identify issues, develop practical solutions, and drive them to closure.
Collaborative approach and willingness to contribute to broader quality responsibilities in a small, cross-functional team.
High integrity and commitment to patient safety.
Travel to supplier sites as required; estimated at 20–30%.

Nice To Haves

Advanced degree in a relevant technical discipline.
ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
Experience supporting or leading first-product commercialization in a medical device startup or small-company environment.
Experience building or significantly improving a supplier quality program from the ground up, ideally in a small- to mid-size medical device company.
Exposure to internal audits, CAPA, and nonconformance management.
Experience with eQMS platforms such as Greenlight Guru, MasterControl, or Veeva Vault.

Responsibilities

Lead qualification and onboarding of suppliers, including developing and executing Supplier Qualification Plans and conducting associated audits.
Assess supplier quality systems, manufacturing capabilities, and risk profiles through desk assessments, on-site audits, and technical reviews.
Maintain the Approved Supplier List and ensure supplier files are current and compliant with QMS requirements.
Work with Procurement and R&D to identify, evaluate, and qualify suppliers for new products and design changes.
Develop and maintain incoming quality control processes, inspection plans, and acceptance criteria for purchased components and materials.
Review and approve First Article Inspection Reports, Certificates of Conformance, and material and dimensional data packages.
Resolve incoming inspection failures and nonconforming material with suppliers in a timely, documented manner.
Support implementation and validation of appropriate statistical sampling plans, including ANSI/ASQ Z1.4 and Z1.9.
Establish supplier scorecards and KPIs for quality, delivery, and responsiveness; conduct periodic performance reviews and communicate findings to stakeholders.
Lead Supplier Corrective Action Request processes and work with suppliers on root cause analysis and corrective and preventive actions.
Escalate chronic supplier performance issues and recommend re-qualification, resource changes, or supplier transitions.
Ensure supplier quality activities comply with FDA 21 CFR Part 820, ISO 13485, and applicable international standards.
Author, review, and maintain supplier quality procedures, work instructions, and records in the QMS.
Support internal and external audits, including FDA inspections and Notified Body audits, by providing supplier quality documentation and evidence.
Participate in Management Review and Quality meetings as a supplier quality subject matter expert.
Contribute to internal audits, nonconformance investigations, CAPA, and QMS maintenance and improvement activities as business needs require.
Provide quality engineering input to design control, risk management, design transfer, product risk assessments, and FMEAs.
Partner with R&D on supplier-related design inputs, specifications, and drawing requirements to ensure manufacturability and quality at source.
Support Manufacturing Operations in resolving supply chain disruptions, material shortages, and nonconformance events.
Drive continuous improvement initiatives in the supplier base and internal receiving and inspection processes.
Apply quality tools such as 8D, Fishbone/Ishikawa, 5-Why, FMEA, and SPC to solve supplier quality problems.
Benchmark supplier quality practices and recommend enhancements as the company grows.
Travel to supplier sites as required for audits, qualification activities, and quality issue resolution.
Perform duties in compliance with Zenflow’s QMS and applicable regulatory requirements.