Senior Quality Engineer

Overview

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.

We are a dynamic medical device start-up seeking a highly skilled and motivated Senior Quality Engineer to join our team. The ideal candidate will play a crucial role in ensuring our products meet the highest standards of quality and regulatory compliance. This position involves working closely with cross-functional teams to support product development, manufacturing, post-market, and overall quality system activities.

Product Development Support:

• Participate in new and modified product development projects.
• Establish product specifications and support manufacturing process validation.
• Develop and review new and revised test methods, validation protocols, and reports (IQ, OQ, PQ).
• Conduct risk management activities, including Hazard Analysis, dFMEA, uFMEA, and pFMEA.

Quality Management System (QMS):

• Maintain and improve the QMS in compliance with FDA, ISO 13485, and other applicable regulatory requirements.
• Conduct internal and supplier audits to ensure compliance with quality standards.
• Support external regulatory body audits and inspections.

Non-Conformance and CAPA:

• Investigate and resolve non-conformances and product complaints.
• Lead root cause analysis and implement corrective and preventive actions (CAPA) as appropriate.
• Track and analyze quality metrics to monitor processes and identify trends and areas for improvement.

Supplier Quality Management:

• Qualify new suppliers and manage supplier performance.
• Conduct supplier audits and supplier re-qualifications to ensure supplier compliance with quality requirements and implementation of corrective actions.

Post-Market Surveillance:

• Review and maintain post-market surveillance data and files.
• Track and report on product-related non-conformances and complaint status.

Continuous Improvement:

• Lead and champion continuous improvement.
• Analyze key performance indicators and drive quality improvements.

• Bachelor’s or Master’s degree in Engineering, Science, or a related field (e.g., Mechanical, Biomedical, Quality Engineering), or equivalent experience.
• Minimum of 5 years of experience in quality engineering, R&D, or manufacturing within the medical device or Med Tech industries, or other appropriate technical experience.
• Certified Quality Engineer (CQE) certification from the American Society for Quality (ASQ) is preferred.
• In-depth knowledge of FDA QSR Part 820, ISO 13485, and EU Medical Device Regulations.
• Hands-on experience with Design Verification and Validation (V&V) test plan development, test method validation, execution, and report review.
• Proficiency in risk management tools such as FMEA and root cause analysis.
• Strong analytical skills and experience with statistical process control and design of experiments, and overall valid statistical analysis.
• Excellent communication and teamwork skills, with the ability to work effectively in a fast-paced start-up environment.
• Experience with Lean Manufacturing tools and techniques is an advantage.
• Experience with collecting, analyzing, and presenting quality system performance data for Management Reviews a plus.
• Familiarity with international regulatory requirements (e.g., MDR, TGA, PMDA) a plus.
• Experience with electronic Quality Management Systems (eQMS) preferred.
• Proven track record of successful project management and leadership in a quality engineering role.
• Ability to work independently and balance multiple priorities in a fast-paced, FDA regulated environment.
• Strong verbal and written communication skills.
• Strong organizational and planning skills, with an attention to detail.

Location & Compensation
This position is based in South San Francisco, CA. The expected salary range for this position is $100,000-$130,000, 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.