Bachelor's degree in engineering or scientific discipline
6 years relevant experience in quality assurance
Experience with fda 21 cfr part 820 and iso 13485
The role involves serving as a Lead Quality Engineer for medical device combination product development programs with a focus on design controls and risk management
Job Summary
The role involves serving as a Lead Quality Engineer for medical device combination product development programs with a focus on design controls and risk management.
Candidates must ensure compliance with regulatory requirements including FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, and ISO 14971.
Gilead offers a competitive salary range of $136,340.00 - $176,440.00 along with discretionary bonuses, stock incentives, and comprehensive benefits.
Matching Summary
The role involves serving as a Lead Quality Engineer for medical device combination product development programs with a focus on design controls and risk management.
Salary
Base: $136,340.00 - $176,440.00; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives available; Benefits: Medical, dental, vision, life insurance, and paid time off
Skills & Requirements
Must-have
Bachelor's degree in Engineering or scientific discipline
6 years relevant experience in Quality Assurance
Experience with FDA 21 CFR Part 820 and ISO 13485
Expertise in design verification and validation activities
Knowledge of ISO 14971 risk management standards
Nice-to-have
8+ years supporting combination products like autoinjectors
Strong project management and process improvement capabilities
Advanced proficiency in statistical methods and MSA
Ability to influence across cross-functional teams
Deep expertise in system-level risk analysis
Key Requirements
Bachelor's degree in Engineering or science with 6 years experience
Master's degree in related field with 4 years experience
Demonstrated experience in Quality Assurance for medical devices
US work authorization required (implied by US job posting)