Quality Engineer

3 weeks ago


Houston, United States BioPharma Consulting JAD Group Full time
BioPharma Consulting JAD Group has a great Associate Quality Engineer with an industry leader working on site in Houston, Texas.

Job Details:

  • Review and approve quality systems control document
  • Review and approves process validation, V&V deliverables, environmental monitoring, risk management, documents and change requests
  • Assist in root cause investigation, CAPA implementation and effectiveness review. Serving as Quality contact for nonconforming product investigation and CAPP or both internal and external sources
  • Participate in a variety of projects serving as quality voice and ensure project is progressing per company, regulatory, authority and industry requirements
  • Serving as quality voice for projects and tasks related to sterilization, environmental monitoring, cleanroom design and operation, laboratory management and endotoxin
  • Complies with all policies and standards
  • Works under general direction, seeks assistance as needed
  • Completes work in accordance with established procedures and practices within field of technical/scientific knowledge
  • Establishes approaches for completing assignments
  • Work requires consistent exercise of discretion and independent judgment
  • Works with team to support achievement of project milestones
  • Builds productive internal/external relationships

Preferred Qualifications:

  • Experience in medical devices industry as Quality representative with review and approval process validation, V&V deliverables, environmental monitoring, risk management, documents and change requests. Root cause investigation, CAPA implementation and effectiveness review experience

Education:

Bachelor's degree in Science or Engineering with 2-4 years of directly related experience
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