Sr Quality Engineer

Katalyst Healthcares & Life Sciences

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JOB DETAILS

LOCATION

Tempe, AZ

POSTED

30+ days ago

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.

Requirements:

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.