Quality Engineer

Intellectt INC

Plano, TX

JOB DETAILS
LOCATION
Plano, TX
POSTED
5 days ago

Hello,
I Hope you are doing great.

This is Mahaboob from Intellectt INC; We have an urgent opening for a Quality Engineer position based in Texas with one of our prestigious clients. Interested candidates can please send your updated resume at

mahaboob.m@intellectt.com

Job Title: Quality Engineer
Location: Texas

Job Overview: We are seeking a detail-oriented and well-rounded Quality Engineer (QE) with experience in the medical device industry. The ideal candidate will support quality systems, validation activities, and ensure compliance with regulatory standards. Experience with combination products (medical device + pharmaceutical components) is highly desirable.

Key Responsibilities:

  • Support and maintain Quality Management Systems (QMS) in compliance with industry standards
  • Perform and support process and equipment validation activities (IQ/OQ/PQ)
  • Ensure adherence to QA regulations, GMP, and medical device standards
  • Collaborate cross-functionally with manufacturing, engineering, and quality teams
  • Assist in root cause analysis, CAPA, and continuous improvement initiatives
  • Review and maintain quality documentation and reports
  • Participate in audits and ensure regulatory compliance

Required Qualifications:

  • Bachelor s degree in Engineering or related field
  • Experience in the medical device industry
  • Strong understanding of process validation and equipment validation
  • Knowledge of QMS, QA regulations, and GMP standards
  • Good communication and teamwork skills

Thanks & Regards,
Mahaboob M
Technical Recruiter
Intellectt Inc
mahaboob.m@intellectt.com
Direct: 732-276-1830
Desk number: 732 412 6999- Ext: 355

About the Company

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Intellectt INC