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 supporting regulatory and agency inspections, audits, and investigations regarding the control and assessment of product design and manufacturing quality.
Employees are eligible for a comprehensive benefits package including 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 adherence to Quality System requirements for medical device manufacturing.
Salary
Base: $77,570 - $113,740; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off
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 Quality Systems (QMS)
Proficiency in Minitab and statistical tools
Nice-to-have
Ability to work independently and in team environment
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 or related field
2-5 years of quality engineering experience
Preferably in medical device or regulated manufacturing
Competence in selection and use of Quality Engineering Tools