Orange County Metro Area, CA
Must have New Product Development experience
Support new product development projects for transcatheter heart valves by leading component qualification activities. Partner with suppliers to execute process and test method validations, capability studies, and FMEAs. Utilize statistical tools to evaluate supplier processes and inspection methods.
Develop, implement, and validate component inspection test methods. Identify opportunities for re-design/design of inspection tools/fixtures/equipment to improve processes and reduce risk.
Investigate quality and compliance issues in Receiving Inspection and Manufacturing for supplied components (NCR, SCAR, CAPA).
Support Initiation of ECRs (Enterprise Change Request) in Ignite. This includes redlining documents per engineer/supervisor instruction.
Participate in project teams to improve Quality.
Previous QE new product development or manufacturing support experience is required.
Root Cause Analysis knowledge required.
Nonconforming material investigation experience required.
Working knowledge of process/product validation required.
Working knowledge of the design control process required.
PC skills and knowledge of MS office (Word, Excel, PowerPoint and Outlook) required.
Must have good verbal / written communication skills, be detail oriented and have good problem solving skills.
Knowledge of Quality Systems, good documentation practices, and data analysis software tools (Minitab) preferred.
Must have BS degree in Engineering
5-10 years of related work experience