The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing
Job Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.
The role involves leading complaint investigations, managing CAPA activities, and ensuring the disposition of non-conforming materials meets all regulatory requirements.
Employees receive a comprehensive benefits package with immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching.
Matching Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure adherence to Quality System requirements for medical device manufacturing.
Salary
Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program included; Benefits: Comprehensive package with medical, dental, vision, 401(k) match, and paid time off
Skills & Requirements
Must-have
Bachelor's Degree in Engineering
2-5 years quality engineering experience
FDA regulations and ISO standards knowledge
Device History Records maintenance
Statistical quality control (Cpk, DOE)
Nice-to-have
Ability to work independently and in team environment
Mentoring technicians and inspectors
Continuous improvement project participation
Effective written and verbal communication
Key Requirements
Minimum Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Experience preferably in medical device or regulated manufacturing