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 who will utilize advanced engineering methods and tools to ensure product quality in the medical device industry. The role involves supporting manufacturing compliance, conducting audits, and engaging in continuous improvement projects while adhering to the company's core values
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, company policies, and Quality Management Systems.
The role includes leading test method validations, managing non-conforming material processes, and supporting regulatory inspections and audits.
Matching Summary
Match Score: 75
Integer is seeking a Quality Engineer II who will utilize advanced engineering methods and tools to ensure product quality in the medical device industry. The role involves supporting manufacturing compliance, conducting audits, and engaging in continuous improvement projects while adhering to the company's core values.
Salary
Base: $70,500 - $103,400; Bonus/Equity: Cash-based incentive program; Benefits: Medical, dental, vision, 401(k) matching, 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 Quality Management Systems (QMS)
Ability to lead test method validations and protocols
Proficiency in root cause analysis and CAPA activities
Nice-to-have
Strong written and oral communication skills
Positive can-do attitude in high-energy environments
Experience with continuous improvement methodologies
Familiarity with Microsoft Office suite
Collaborative team player mindset
Key Requirements
Bachelor's degree in engineering or related field
Minimum 3 years of relevant experience
Awareness of domestic and international regulations (ISO, QSR, UL)