Quality Engineer II

Job Title: Quality Engineer II (Contract – Onsite, Morrisville, NC)

Location: Morrisville, NC

Type: Contract (1 year, potential for conversion)

Rate: $37.50 – $44/hr

About the Role:

We are seeking a Quality Engineer II to join a leading life sciences manufacturing organization. This is a fully onsite role in Morrisville, NC, with potential flexibility for occasional remote days. The ideal candidate will have a strong background in quality engineering within pharmaceutical, biotech, or medical device environments and be experienced in complaints, audits, deviation management, and CAPA.

Key Responsibilities:

• Lead investigations, root cause analysis, and resolution of quality events, complaints, CAPAs, and SCARs.
• Coordinate and maintain complaint management, CAPA, and quality systems.
• Review, approve, and implement quality assurance procedures, reports, and methods.
• Support validation activities, process controls, and calibration programs.
• Facilitate internal and supplier audits to ensure compliance with regulatory standards.
• Conduct risk assessments and statistical analysis to support product quality and process improvement.
• Participate in quality management initiatives and continuous improvement projects.
• Collaborate cross-functionally with all levels of employees to maintain and improve quality standards.

Required Skills & Experience:

• Bachelor’s degree in a natural/life science or related field.
• 3–5 years of quality engineering or quality assurance experience in pharmaceutical, biotech, or medical device industries.
• Proven experience with audits (internal and external), CAPA, and complaint management.
• Strong knowledge of GMP, ISO 9001:2015, and QMS systems.
• Proficiency in Microsoft Office (Word, Excel, Access, Outlook).
• Strong analytical, problem-solving, and technical writing skills.
• Excellent interpersonal and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Experience with lean methodologies and continuous improvement initiatives.
• Experience developing protocols, method transfers, and training programs.

Schedule & Worksite:

• Monday–Friday, 7:30 AM–4:00 PM (flexible start time possible).
• Fully onsite at Morrisville, NC.

Why This Role:

This is an exciting opportunity for a quality professional to make a tangible impact on a growing organization while working in a collaborative and regulatory-driven environment. You’ll be part of a team dedicated to quality excellence and continuous improvement.