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Quality Engineer II

Quality Engineer II

Recruits LabMorrisville, NC, United States
10 days ago
Job type
  • Full-time
Job description

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.

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