Quality Engineer Medical Device Manufacturing

Quality Engineer / Quality Assurance Engineer

My client a growing healthcare products manufacturer is hiring a Quality Engineer to keep production compliant and continuously improving with real influence on product reliability for patients who depend on it.

No C2C or third-party firms. Unable to sponsor employment visas now or in the future.

Why you should apply

• Own quality systems end to end with real influence over how products get made
• Work cross-functionally with operations inspectors and quality consultants as part of a tight-knit team
• Base salary $80000 to $90000 DOE
• Full benefits package including medical dental vision and 401k

What youll be doing

• Support quality validations and investigations including non-conformances
• Manage quality test methods and validate standards used in production
• Keep production compliant with FDA GMP and ISO medical device requirements
• Lead root cause investigations for SCARs non-conformances and CAPAs then develop corrective actions
• Apply engineering and statistical tools to reduce failures and improve reliability
• Support audits and train quality inspectors on clean product release

About you

• Be able to do the job as described.
• Bachelors degree in quality industrial or mechanical engineering
• Working knowledge of 21 CFR Part 820 and 803 and ISO 13485
• ASQ certification a plus
• Strong technical writing and root cause investigation skills

Additional Information

• Applicants must be authorized to work in the United States without the need for current or future employer-sponsored work authorization.
• At this time my client is unable to sponsor employment visas for this role now or in the future.

How to apply

Wed love to see your resume but we dont need it to have a conversation. Email Cat at and tell me why youre interested. Or if you do have a resume ready apply here.

Required Experience:

IC