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

Pay rate: $44h

Additional Information

• This role will not accept visa sponsorship (including H-1B and other visas).

• Position is available only as W2 contract-to-hire.

• C2C arrangements will not be considered.

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.