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.