Base: not specified; bonus/equity: cash-based ince...
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry
Job Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
You will support regulatory inspections, monitor manufacturing compliance, and ensure complete and correct Device History Records are maintained.
Our total rewards program includes base salary, a cash-based incentive program, comprehensive benefits with immediate eligibility, and a 401(k) plan with company matching.
Matching Summary
The primary purpose of this position is to perform work involving general engineering methods while utilizing advanced quality tools in the medical device industry.
Salary
Base: Not specified; Bonus/Equity: Cash-based incentive program supporting pay-for-performance; Benefits: Comprehensive package including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) with matching
Skills & Requirements
Must-have
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of FDA regulations and ISO standards
Experience with QMS and Device History Records
Ability to lead CAPA investigations and root cause analysis
Nice-to-have
Positive can-do attitude in high-energy environment
Strong written and oral communication skills
Experience with process capability studies
Familiarity with 5S and visual controls
Collaborative team player with problem-solving mindset
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)