FDA-approved Zenflow Spring offers long-lasting BPH relief without side effects or surgical trauma. 62% symptom improvement, 0% reintervention at 12 months. Backed by Y Combinator.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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)
More about this role
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,...
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