Quality Engineer

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

Requirements