Sr. Quality Engineer – Supplier, Design & Operations Quality

Sr. Quality Engineer
- Supplier, Design & Operations Quality

Sr. Quality Engineer
- Supplier, Design & Operations Quality

Reports to: Director of Quality Assurance

Workplace type: Onsite 5 days a week

Location: Santa Cruz, California (moving to Los Gatos, CA in Q1 2027)

Position Type: Full-time

Versa Vascular is an innovative medical device startup developing next-generation implantable solutions for the treatment of tricuspid heart valve disease. Our mission is to improve patient outcomes through precision engineering, rigorous quality standards, and collaborative innovation.

The Senior Quality Engineer provides cross-functional quality engineering support across Supplier Quality (50%), Design Quality (30%), and Operations Quality (20%) for Versa Vascular’s structural heart implants, delivery systems, and accessories.

This hands-on role supports the product lifecycle from supplier qualification and incoming materials through design development, verification and validation, manufacturing, and product release. The position partners closely with R&D, Manufacturing, Supply Chain, and suppliers to resolve quality issues, establish effective controls, and drive continuous improvement in an early-stage medical device environment.

• Develop and maintain supplier quality processes for materials, components, subassemblies, and contract-manufactured products.
• Partner with Supply Chain, R&D, and Operations to establish supplier requirements, specifications, acceptance criteria, and inspection strategies.
• Support supplier selection, qualification, onboarding, audits, and quality agreements.
• Establish risk-based supplier controls, including incoming inspection, sampling plans, COCs, and documentation requirements.
• Lead or support supplier NCRs, SCARs, CAPAs, root-cause investigations, and effectiveness checks.
• Monitor supplier performance and drive corrective actions and continuous improvement.
• Support supplier process, material, and other changes through change control.

• Provide Quality Engineering support to R&D throughout product development and represent Quality on design teams and reviews.
• Support Design Controls in accordance with FDA and ISO 13485 requirements.
• Provide quality input to design requirements, specifications, acceptance criteria, and design outputs.
• Participate in risk management, including FMEA, hazard analysis, risk controls, and residual risk evaluation.
• Support verification and validation activities, including protocols, reports, acceptance criteria, and deviations.
• Support design transfer to ensure product requirements are effectively translated into manufacturing and supplier requirements.
• Apply statistical and quality engineering methods to evaluate product and process performance.
• Support design changes and investigations of development-related quality issues.

• Provide quality engineering support for incoming inspection, manufacturing, in-process inspection, and finished product release.
• Partner with Manufacturing and Engineering to resolve nonconformances and improve process quality, yield, and robustness.
• Lead or support root-cause investigations, CAPA, NCR, and MRB activities.
• Review manufacturing processes, work instructions, inspection methods, and quality documentation.
• Support process validation, including IQ/OQ/PQ, process characterization, and validation of inspection and test methods.
• Support finished goods inspection and product release.

• Working knowledge of FDA medical device regulations and ISO 13485.
• Experience with supplier qualification, audits, supplier NCRs, SCARs, CAPAs, and supplier changes.
• Experience with Design Controls, risk management,…