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 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 included; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match
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 international standards
Ability to work independently and in teams
Mentoring technicians and inspectors
Continuous improvement project participation
Effective written and verbal communication
Key Requirements
Bachelor's Degree in Engineering or related field
2-5 years quality engineering experience
Preferably in medical device or regulated manufacturing