The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry
Job Summary
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry.
You will support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Our total rewards program includes base salary, a cash-based incentive program, and a comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
Matching Summary
The primary purpose of this position is to perform work which involves general engineering methods and tools, utilizing more advanced quality tools and concepts while developing your role as a quality engineering in the medical device industry.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Test method validations
Process validations and capability studies
Non-conforming material disposition
Root cause analysis
Nice-to-have
Collaborate with cross-functional teams
Calm demeanor in high-energy environment
Positive, can-do attitude
Continuous improvement suggestions
Key Requirements
Bachelor's degree in engineering or related field
3 years relevant experience
7+ years relevant experience (if education requirement not met)
Awareness of Domestic and International Regulations and Industry Standards