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 including medical, dental, vision, disability, life insurance, and immediate eligibility for 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; 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)
Minitab proficiency
Nice-to-have
Ability to work independently and in teams
Effective written and verbal communication
Experience with supplier quality resolution
Continuous improvement project participation
Root cause analysis expertise
Key Requirements
Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Preferably in medical device or regulated manufacturing