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 supporting regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
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 that the Quality System requirements are adhered to 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
Mentoring experience for technicians and inspectors
Participation in continuous improvement projects
Key Requirements
Minimum Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience preferred in medical devices
Competence in selection and use of Quality Engineering Tools