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, participating in plant CAPA activities, and ensuring the disposition of non-conforming materials meets regulatory requirements.
Employees are eligible for a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate 401(k) matching contributions.
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 available; Benefits: Medical, dental, vision, disability, life insurance, 401(k) match
Skills & Requirements
Must-have
Bachelor's Degree in Engineering
2-5 years quality engineering experience
FDA regulations and QMS knowledge
Device History Records maintenance
Statistical quality control (Cpk, DOE)
Nice-to-have
Ability to work independently and in teams
Effective written and verbal communication
Mentoring technicians and inspectors
Continuous improvement project participation
Key Requirements
Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Experience in medical device or regulated manufacturing