Senior QA Engineer: Medical Devices, Supplier & Design

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 Position Summary 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. Key Responsibilities Supplier Quality – 50% 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. Design Quality – 30% 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. Operations Quality – 20% 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. Quality Systems & Technical Skill 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, verification and validation, and design transfer. Experience with manufacturing quality, incoming inspection, NCR/MRB, and process improvement. Proficiency with root-cause analysis, CAPA, statistical methods, SPC, process capability, sampling, MSA, and gauge R&R. Familiarity with metrology, calibration systems, and inspection equipment. Ability to develop objective acceptance criteria, inspection methods, and risk-based quality controls. Strong technical communication and ability to work effectively with suppliers and cross-functional teams. Support QMS improvement, audits, regulatory readiness, and maintenance of quality records. Requirements Bachelor’s degree in Engineering or related technical discipline; Master’s degree a plus. 5–8+ years of quality engineering experience in medical devices or another highly regulated industry. Demonstrated experience across supplier, design, and/or manufacturing quality. Strong working knowledge of FDA requirements and ISO 13485. Experience resolving complex technical quality issues with suppliers and cross-functional teams. Experience in a startup or early-stage medical device environment highly desirable. Why Join Versa Vascular Help bring innovative structural heart therapies to patients with significant unmet clinical needs. Work alongside a highly experienced team of clinical, engineering, and cardiovascular experts. Influence clinical strategy and execution at a critical stage of company growth. Competitive compensation, equity participation, and comprehensive benefits. Collaborative culture that values innovation, ownership, and professional development. Opportunity to make a meaningful impact on the future of cardiovascular care. Versa Vascular is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, gender identity, sexual orientation, or any other protected characteristic under applicable law. Apply Today! We look forward to hearing from you. First Name * Last Name * Email * Resume * Accepted file types: png, pdf, Max. file size: 8 MB. Accepted file types: png, pdf, Max. file size: 50 MB. #J-18808-Ljbffr Versa Vascular