Medical Device Validation Engineer
Los Angeles, CA
Medical Device Sr. Validation Engineer
Our client is a large medical device manufacturer of class II and III products. They are currently looking for a Sr Validation Engineer that will be supporting several software projects including SAP and Trackwise.
Duties & Responsibilities:
The ideal candidate will have 7-10 years of experience in software validation of R&D, Manufacturing and large scale computer systems (e.g. HP Quality Center, SAP, Trackwise, Enovia, Windchill, DOORS, etc.) They will be working in a disciplined regulated industry in the application of automated technology particularly in 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5. They will need to have experience and good understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections. They will be leading and educating teams on the appropriate validation documentation created as objective evidence for software validations per company procedures, standards and regulations. They will be resposnbile for writing master validation plans as well as executing (IQ) Installation Qualification, (OQ) Operational Qualification, (PQ) Performance Qualification, (UAT) User Acceptance Testing, (SAT) System Acceptance Testing.
They will be working with cross functional teams and need to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives. There might 15% travel required to domestic and international sites. Speaking Spanish is a plus but not required. Experience in software development (e.g. design, development testing etc. as well as certifications in related to software development, Quality Management Systems would also be a plus.
Job Type: Contract