Sr. Quality Engineer

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Purpose of the Job

The Sr. Quality Specialist will ensure fulfillment of quality activities related to Quality Systems and Production Quality, in accordance with applicable medical device standards and regulations.

About Ventaris Surgical

Ventaris Surgical is a venture-backed medical device company founded in 2024 and headquartered in San Carlos, California. Backed by leading MedTech investors following a $30 million Series A financing, we are developing a next-generation ureteroscopic system designed to help surgeons achieve more complete kidney stone clearance in a single procedure while reducing the physical and cognitive burden of treatment.

Kidney stone disease is one of the world's most common urologic conditions. Nearly 1 in 10 people will experience a kidney stone in their lifetime, and more than 500,000 people undergo kidney stone surgery in the U.S. each year. Yet today's tools make it difficult for surgeons to consistently achieve complete stone clearance. Our vision is simple: every patient stone-free through a single procedure.

Major Responsibilities

• Document Control coordination. Guides the team and ensures Document Control practices are being followed. Resolves issues related to document control, sets up new workflows in eQMS, resolves issues. Sets up training curriculum and runs reports.
• Performs QC Inspection on finished products or subassemblies.
• Performs sterile release review to ensure finished product meets the requirements for release.
• Reviews Quality records ( Lot history record, inspection records, etc) ensuring completion, acceptability, compliance, and good documentation practices.
• Performs supplier qualifications.
• Oversee CAPAs and NCRs system to ensure timeliness of completion.
• Coordinates activities such as Calibration, PM activities, Cleanroom monitoring etc.
• Creates quarterly Quality metrics.
• May perform lot release testing on finished product.

Qualifications

• Minimum of 5 years of experience in Quality for medical devices.
• Strong knowledge of medical device GMPs, ISO 13485.Prior experience as Document control administrator expected.
• Strong communications skill (verbal and written).
• Ability to work effectively in a dynamic, less structured, fast-paced environment.
• Good time management and excellent communication skills.
• Strong attention to detail.

Note: This role requires on-site presence 5 days/a week.

Education & Experience

College degree preferred.

Why Join Ventaris

• High impact from day one: we are a small team, and every role is mission-critical
• A clear, compelling vision: every patient stone-free through a single procedure
• A rare moment to help define a new standard of care, at a point when the field is still shifting away from incremental improvements
• Backed by leading MedTech investors following a $30 million Series A financing
• A low-ego, high-accountability culture grounded in collaboration, candor, and conviction

Who We're Looking For

• We are a values-based company. Our values guide how we work and make decisions:
• Collaboration: Time and attention are finite. Meetings are purposeful. Own your work, be accountable, and drive to closure. Asking for help is a strength, not a weakness.
• Candor: Speak up early, directly, and respectfully. Debate ideas, not people. Raise concerns when they are small. Avoid politics, passivity, and condescension.
• Conviction: Let the mission guide every decision. Make hard tradeoffs for the collective good. Focus on getting it right over being right. Challenge each other, then commit fully.

Ventaris Surgical is an equal opportunity employer and considers qualified applicants without regard to any characteristic protected by applicable law.