The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing
Job Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing.
The role involves leading complaint investigations, participating in plant CAPA activities, and ensuring the disposition of non-conforming materials meets all necessary regulatory requirements.
Employees receive a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching contributions.
Matching Summary
The primary purpose of this job is to provide Quality Engineering support for Operations to ensure that the Quality System requirements are adhered to for medical device manufacturing.
Salary
Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program supporting pay-for-performance philosophy; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with matching
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 tools
Nice-to-have
Experience with ISO and MDD standards
Ability to work independently
Strong written and verbal communication
Mentoring technicians and inspectors
Continuous improvement project participation
Key Requirements
Minimum Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Preferably in medical device or regulated manufacturing