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.
Candidates will lead the generation and completion of protocols for test method validations and review changes to Bill of Materials and Assembly Procedures.
The company offers a comprehensive benefits package including medical, dental, vision, disability, life insurance, and immediate eligibility for a 401(k) plan with 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: Comprehensive package including medical, dental, vision, 401(k) match
Skills & Requirements
Must-have
Bachelor's Degree in Engineering
2-5 years quality engineering experience
Knowledge of FDA regulations and ISO standards
Experience with Medical Device Manufacturing
Proficiency in Minitab and statistical tools
Nice-to-have
Ability to work independently and in teams
Strong written and verbal communication skills
Experience leading complaint investigations
Mentoring technicians and inspectors
Participation in continuous improvement projects
Key Requirements
Minimum Bachelor's Degree in Engineering
2-5 years of quality engineering experience
Preferably in medical device or regulated manufacturing