Sr. Quality Engineer - Katalyst Healthcares & Life Sciences

Top 3 skills:

• 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

Description:
In this Senior Quality Engineer for Operations Quality, you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable electronic products at client's Tempe Campus.

Responsibilities :

• The Sr. Manufacturing Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
• 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.
• Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the manufacturing team that enable high product quality via Process and Test Method Validations.
• 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.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.
• 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 performing the role of Quality Engineer.
• Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives.
• Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and projects simultaneously
• Communicate clearly regarding technical issues and solutions

Duties:

• 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

Must Haves:

• Strong background in Equipment Development, IQ, Process Characterization, OQ/PQ, and Test Method Development and Validation.
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Strong Client, CAPA and investigation experience
• Strong understanding of product/process risk management (D/PFMEAs)

Nice To Haves:

• Experience with electronics manufacturing including wafer fabs and electronicsassembly.
• Six Sigma or DRM certification
• Strong statistical analysis techniques