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