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 generation and completion of protocols and reports for test method validations while reviewing changes to Bill of Materials and Assembly Procedures.
Employees receive a comprehensive benefits package including 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 that the Quality System requirements are adhered to 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 ISO standards knowledge
Device History Records maintenance
CAPA and root cause analysis expertise
Nice-to-have
Experience with Minitab statistical software
Ability to work independently and in teams
Strong written and verbal communication skills
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