Senior Quality Supplier Engineer

Zenflow•South San Francisco, CA

2d•Onsite

About The Position

Zenflow, Inc. is a privately held medical device company developing treatments for urinary obstruction caused by enlarged prostate. Its Spring System is FDA approved for commercial sale. The Senior Quality Engineer is responsible for establishing, managing, and continuously improving 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 core focus, with additional support for internal audits, CAPA, nonconformance management, and quality system improvements as needed. The position works cross-functionally with R&D, Manufacturing Operations, Procurement, and Regulatory to qualify suppliers, manage performance, resolve supply-chain quality issues, and support new product introductions and design changes. It operates with a high degree of independence and ownership and helps build scalable supplier quality systems for future products. This 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.
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 to ISO 13485 or 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 manage supplier relationships independently, including performance discussions, corrective actions, and escalations.
Strong technical writing skills and ability to author 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, and highly organized, with a proactive ownership mindset and ability to drive issues to closure.
Collaborative team player who can flex into broader quality responsibilities as business needs require.
High integrity and commitment to patient safety.

Nice To Haves

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

Responsibilities

Lead qualification of new suppliers, including developing and executing Supplier Qualification Plans and conducting associated audits.
Evaluate 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 complete, current, and compliant with QMS requirements.
Work 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 processes, inspection plans, and acceptance criteria.
Review and approve First Article Inspection Reports, Certificates of Conformance, and material or dimensional data packages.
Drive timely, documented resolution of incoming inspection failures and nonconforming material with suppliers.
Support implementation and validation of statistical sampling plans appropriate for a commercial-stage medical device company.
Establish and maintain supplier scorecards and KPIs for quality, delivery, and responsiveness.
Lead Supplier Corrective Action Request processes and work with suppliers on root cause analysis and corrective and preventive actions.
Conduct periodic supplier performance reviews, communicate findings to internal stakeholders, and escalate chronic performance issues.
Recommend supplier re-qualification, resource changes, or transitions when appropriate.
Ensure supplier quality activities comply with FDA 21 CFR Part 820, ISO 13485, and applicable international standards.
Author, review, and maintain supplier quality SOPs, work instructions, and quality 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, new product development, and product risk assessments and FMEAs.
Partner with R&D to review supplier-related design inputs, specifications, and drawings for manufacturability and quality at source.
Support Manufacturing Operations in resolving supply-chain disruptions, material shortages, and nonconformance events.
Identify and drive continuous improvement initiatives with suppliers and in 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 improvements as the company scales.
Perform duties in compliance with Zenflow’s QMS and applicable regulatory requirements.
Travel to supplier sites to conduct audits, support qualification activities, or resolve quality issues.