Not specified (assumed onsite based on job location)
Quality management systems (qms)
Fda regulations
Device history records (dhr)
Integer is seeking a Quality Engineer II in Alden, US, to enhance product quality in the medical device sector. The role involves applying engineering methods, supporting manufacturing processes, and ensuring compliance with quality standards while fostering a collaborative and innovative workplace culture
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.
Our total rewards program is designed to attract, retain, and motivate associates to contribute to Integer’s success, including base salary, a cash-based incentive program, and a comprehensive benefits package.
Matching Summary
Match Score: 85
Integer is seeking a Quality Engineer II in Alden, US, to enhance product quality in the medical device sector. The role involves applying engineering methods, supporting manufacturing processes, and ensuring compliance with quality standards while fostering a collaborative and innovative workplace culture.
Salary
Base: 70,500 - 103,400; Bonus/Equity: cash-based incentive program; Benefits: medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with company matching, 80 hours holidays, paid time off
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
Device History Records (DHR)
Test method validation protocols
Non-conforming material disposition
Root cause analysis
Nice-to-have
Collaborative team environment
Positive can-do attitude
Calm demeanor in high-energy environment
Continuous improvement suggestions
Key Requirements
Bachelor's degree in engineering or related field
3+ years relevant experience
7+ years relevant experience (alternative)
Awareness of Domestic and International Regulations