Infosoft, Inc. · 15 hours ago
Quality Engineer (Medical Devices) - (USC/GC Only)
Irvine, CA
Contract
Onsite
Senior Level
$65/hr - $70/hr
6+ years expInfosoft, Inc. is dedicated to advancing medical innovations for structural heart disease and critical care. The Quality Engineer will collaborate with R&D and Manufacturing teams to develop tools and technologies while ensuring compliance with industry regulations.
ConsultingDeliveryHuman ResourcesInformation Technology
No H1B
U.S. Citizen OnlyHiring Manager
Jack J
Responsibilities
Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations
Manage cross-functional projects, timelines, and budgets; implement digital quality tools ( eQMS , dashboards )
Translate technical information to all levels of the organization through large and small presentations
Independently lead QMS improvement activities and associated projects
Own and perform documentation changes and set policies and standards that are followed by others
Lead CAPA execution, root cause investigations , and quality data analysis to identify trends
Own and drive validation testing (all types), TMV , and software validation testing
Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement
Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk
Drive development and manage execution of complex experiments and tests (including writing and executing protocols ) to validate and improve products and establish robust manufacturing processes; ensure completion of p rocess validations (IQ/OQ/PQ) , analyze results, and develop reports
Qualification
Required
Bachelor's or master's degree in engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences)
6 years of experience in medical device engineering or medical device quality roles
Travel required ~15%
Statistical-based software (Minitab, JMP)
Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations, and develop reports
Proficiency in quality tools (FMEA, CAPA, statistical analysis)
Preferred
Certified Quality Engineer (CQE) or equivalent
Measurement and Test Equipment knowledge and experience are essential
Process Validation experience
Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge)
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase