Bachelor's degree in engineering or related technical field
Three years of relevant engineering experience
Knowledge of fda regulations and quality management systems
The primary purpose of this position is to develop and implement new product and process technologies while ensuring compliance with FDA regulations and company quality standards
Job Summary
The primary purpose of this position is to develop and implement new product and process technologies while ensuring compliance with FDA regulations and company quality standards.
Candidates will work independently to evaluate existing products and processes for failure analysis and potential improvements using standard data analysis practices.
This role requires embedding quality within the engineering discipline by adhering to the Quality Management System and contributing to the attainment of quality KPIs.
Matching Summary
The primary purpose of this position is to develop and implement new product and process technologies while ensuring compliance with FDA regulations and company quality standards.
Skills & Requirements
Must-have
Bachelor's degree in engineering or related technical field
Three years of relevant engineering experience
Knowledge of FDA regulations and Quality Management Systems
Ability to perform root cause analysis for product failures
Experience with continuous improvement methodologies
Nice-to-have
Proactive insight into technical challenges
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Familiarity with Integer Production System principles
Collaborative mindset across cross-functional teams
Key Requirements
Minimum bachelor's degree in engineering
At least three years of relevant experience
Functional understanding of QMS documentation tasks