Not specified (assumed to be hybrid or onsite based on industry norms).
Bachelor's degree in engineering or related field
3 years relevant experience in quality engineering
Knowledge of fda regulations and iso standards
Integer is seeking a Quality Engineer II to support quality management processes within the medical device industry. The ideal candidate should have a bachelor's degree in engineering or a related field, along with relevant experience, and possess strong analytical and communication skills
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 ensure internal and external customer expectations are met by adhering to FDA regulations, Quality Management Systems, and company safety requirements.
The role includes leading complaint investigations, managing non-conforming material processes, and supporting continuous improvement projects to achieve quality KPIs.
Matching Summary
Match Score: 85
Integer is seeking a Quality Engineer II to support quality management processes within the medical device industry. The ideal candidate should have a bachelor's degree in engineering or a related field, along with relevant experience, and possess strong analytical and communication skills.
Salary
Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program included; Benefits: Medical, dental, vision, 401(k) match, paid time off
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
Proficiency in root cause analysis and CAPA
Ability to lead test method validations
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environment
Collaborative team player with cross-functional experience
Familiarity with 5S and visual controls
Experience with product transfers and process improvements
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)