Senior Operations Quality Engineer

Versa Vascular·
Santa Cruz, CA (Hybrid)
2w ago
Full-timeMidManufacturing and OperationsCardiovascularUnknownBachelors
Market Rate — Industrial Engineers
25th
$78K
Median
$99K
75th
$123K

BLS 2024 data (national)

Description

The Senior Operations Quality Engineer is responsible for providing quality engineering support to IQC, the manufacturing line, supporting finished goods release and development efforts for Versa’s structural heart implant, delivery system and accessories. Responsibilities include overseeing product quality during all stages of production, collaborating with Manufacturing and Engineering teams to resolve quality issues, reviewing material specifications, maintaining incoming inspection programs, supervising material inspections, leading investigations into nonconforming materials, performing statistical analysis, supporting process validations, developing validation protocols, and ensuring compliance with quality standards. The role also includes providing quality input to design and clinical readiness reviews, collaborating with R&D and Clinical teams on design controls, participating in risk management processes, maintaining documentation, and supporting audits.

Requirements

Bachelor’s degree in Engineering or a related technical field. Master’s degree is a plus. 5-8 years of experience in medical device quality engineering. Knowledge of FDA regulations, ISO 13485, and other relevant quality standards for medical devices. Experience in a cleanroom environment preferred. Experience with nonconforming material investigations and CAPAs. Experience in startup environments is highly desirable.
Versa Vascular

Versa Vascular

BIOTECHNOLOGY

Tricuspid Repair solution

LocationCA - Santa Cruz
Open Jobs4
Cardiovascular
View Company Profile

Pipeline

Versa ImplantN/A