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 engineer 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 engineer 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, and monitor manufacturing of assigned products, assuring compliance with DMR.
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 engineer in the medical device industry.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Bill of Materials (BOMs) review
process validations
corrective and preventive actions (CAPA)
Nice-to-have
calm demeanor
positive can-do attitude
Manufacturing Excellence strategies
Market Focused Innovation strategies
behavior-based safety programs
Key Requirements
Bachelor's degree in engineering or related field and 3 years relevant experience
7+ years relevant experience (if education requirement not met)
Awareness of Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)