IntePros
Senior Quality Engineer – GMP / Medical Device
Seeking an experienced Senior Quality Engineer to support and enhance the Quality Management System (QMS) for a leading medical device manufacturer. This role leads CAPAs, drives process improvements, and ensures compliance with FDA, ISO 13485, and GMP requirements.
Base Pay Range $35.00/hr - $50.00/hr
Key Responsibilities
Lead root cause investigations and manage CAPAs.
Support internal/external audits and regulatory inspections.
Oversee complaint investigations and quality data analysis.
Provide quality oversight for engineering changes and validations.
Partner with cross-functional teams to improve processes and compliance.
Qualifications
Bachelor’s degree in Engineering or related field.
5+ years
of Quality Engineering experience (medical device/pharma).
Strong knowledge of FDA 21 CFR 820, ISO 13485, and GMP.
Experience with CAPA, risk management, and audits.
Six Sigma/Lean experience preferred.
Onsite role, full-time hours.
Must be authorized to work in the U.S.
No sponsorship or C2C.
Employment type Contract – 6+ month assignment
Seniority level Mid-Senior level
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Base Pay Range $35.00/hr - $50.00/hr
Key Responsibilities
Lead root cause investigations and manage CAPAs.
Support internal/external audits and regulatory inspections.
Oversee complaint investigations and quality data analysis.
Provide quality oversight for engineering changes and validations.
Partner with cross-functional teams to improve processes and compliance.
Qualifications
Bachelor’s degree in Engineering or related field.
5+ years
of Quality Engineering experience (medical device/pharma).
Strong knowledge of FDA 21 CFR 820, ISO 13485, and GMP.
Experience with CAPA, risk management, and audits.
Six Sigma/Lean experience preferred.
Onsite role, full-time hours.
Must be authorized to work in the U.S.
No sponsorship or C2C.
Employment type Contract – 6+ month assignment
Seniority level Mid-Senior level
#J-18808-Ljbffr