What are the responsibilities and job description for the Sr Quality Engineer position at Katalyst CRO?
Responsibilities
- In this Sr Quality Systems Specialist for Operations Quality, you will have responsibility for the Quality and Compliance of process development.
- Manufacturing of implantable electronic products at our client Tempe Campus.
- Responsibilities may include the following and other duties may be assigned.
- Ensure internal quality processes, procedures and systems are compliant to all governing standards.
- Support manufacturing development and continuous improvement as the Quality team member for process development and validation including.
- Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.
- Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing. engineers in the development of compliant test plans and reports.
- Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
- Support CAPA investigations, improvements, and effectiveness verification testing.
- Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously.
- Bachelor's degree.
- Strong understanding of operations/manufacturing processes and products; Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics.
- Ability to work independently and provide comprehensive feedback on complex issues, support risk assessment processes for manufacturing and development.
- Strong Communication Skills (verbal and written).
- Someone from the Medical Device or Medical Manufacturing industry is required.
