Job Title: Medical Device Senior Quality Engineer
Job Location: Tempe, Arizona (Fully Onsite)
Type: W2 contract
Technical skills that are required for the role:
Strong background in IQ, Process Characterization, OQPQ, and Test Method Development and Validation
Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
Strong understanding of medical device manufacturing processes and products
Education Required: Bachelor’s degree in Engineering or technical discipline.
Years’ Experience Required: 4+ years of engineering experience in a medical device manufacturing environment
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.