Jacobs Management Group
Quality Engineer
We’re seeking a
Quality Engineer II
to join the team in Morrisville, NC. This role requires strong experience in quality systems, audits, CAPAs, and root cause analysis, with a background in GMP-regulated industries. 12 months contract- contract to hire $44h Key Responsibilities Lead and support quality events, complaints, CAPAs, SCARs, and audits (internal and supplier).
Manage and maintain systems for complaints, CAPAs, calibration, validations, and environmental monitoring.
Develop, review, and approve quality methods, procedures, and reports.
Support manufacturing operations with process controls and validations.
Conduct root cause investigations, risk assessments, and statistical quality analysis.
Collaborate across departments to drive compliance with regulatory standards and continuous improvement initiatives (ABS, Lean).
Provide training, technical writing, and quality-related guidance at all organizational levels.
Qualifications Bachelor’s degree in a life/natural science field (preferred in medical device, biotech, or pharma).
3–5 years of experience in Quality Engineering/Assurance or similar role.
Proven experience with audits, CAPAs, and QMS/ERP systems.
GMP knowledge and ISO 9001:2015 familiarity required.
Strong problem-solving, technical writing, and organizational skills.
CQE/CQA certification preferred.
Quality Engineer II
to join the team in Morrisville, NC. This role requires strong experience in quality systems, audits, CAPAs, and root cause analysis, with a background in GMP-regulated industries. 12 months contract- contract to hire $44h Key Responsibilities Lead and support quality events, complaints, CAPAs, SCARs, and audits (internal and supplier).
Manage and maintain systems for complaints, CAPAs, calibration, validations, and environmental monitoring.
Develop, review, and approve quality methods, procedures, and reports.
Support manufacturing operations with process controls and validations.
Conduct root cause investigations, risk assessments, and statistical quality analysis.
Collaborate across departments to drive compliance with regulatory standards and continuous improvement initiatives (ABS, Lean).
Provide training, technical writing, and quality-related guidance at all organizational levels.
Qualifications Bachelor’s degree in a life/natural science field (preferred in medical device, biotech, or pharma).
3–5 years of experience in Quality Engineering/Assurance or similar role.
Proven experience with audits, CAPAs, and QMS/ERP systems.
GMP knowledge and ISO 9001:2015 familiarity required.
Strong problem-solving, technical writing, and organizational skills.
CQE/CQA certification preferred.