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, comprehensive benefits with immediate eligibility, and 401(k) with company matching contributions.
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)
test method validation protocols
process validation and capability studies
non-conforming material disposition
corrective and preventive actions (CAPA)
Nice-to-have
customer success focus
innovation and continuous improvement
collaboration with cross-functional teams
respectful interaction
open and honest communication
integrity in actions
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.)
Good knowledge in Microsoft Office
Ability to work independently and collaboratively
Competencies in written and oral English communications