Quality Engineer II

Viant•Fremont, CA

22h•$121,264 - $126,000•Onsite

About The Position

The Quality Engineer II is responsible for ensuring quality activities are performed in accordance with 21 CFR 820, ISO 13485, ISO 14971 and other relevant FDA and International regulations. Specific duties include: (1) independently maintaining compliance, monitoring the effectiveness of, and updating Meraqi’s Quality Management System (QMS) through SOP and QWI updates; (2) planning and executing sterilization validations using ethylene oxide, gamma and e-beam radiation; (3) monitoring ongoing sterilization process effectiveness for Class II and Class III devices through dose audits and cleanroom monitoring; (4) conducting and evaluating biological risks for Class III implantable devices; (5) providing quality input for reprocessing and cleaning validation of reusable medical devices; (6) providing product development oversight for Class II and III medical devices with focus on Design Control, Change Control, Risk Management, Production and Process Controls; (7) leading as a QA representative in design/phase reviews throughout the product development life cycle and providing critical feedback; (8) designing and implementing Device Master Record (DMR) features such as Manufacturing Process Instructions (MPI), Bill of Materials (BOM), Lot History Records (LHR), risk analyses including Clinical Hazard Analysis (CHA), Failure Modes and Effects Analysis (FMEAs), etc. and Quality Process Instructions (QPI); (9) leading feasibility studies of the design to determine product ability to function as intended; (10) maintaining detailed Design History Files (DHF) of medical devices throughout all phases of the Design Control process; (11) developing, documenting and updating risk analyses through Risk Management Summary Reports (RMSR), Risk Registers, FMEAs and Hazard Analyses (HA); (12) developing and reviewing verification and validation test protocols and reports; (13) creating, classifying and reviewing equipment for process validation activities such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ); (14) independently leading the investigation and closure of Corrective Actions and Preventive Actions (CAPA), and Non-Conforming Material Report (NCMRs); (15) developing objective evidence through data collection and statistical analyses to support customer regulatory submissions and related critical activities such as validations; (16) ensuring supplier quality systems meet Meraqi Medical, Inc. requirements; (17) leading training sessions of company employees in Quality System procedures and processes; and (18) providing software quality assurance, reviewing and approving Software Requirements Specifications (SRS), Software Hazard Analysis and Software Architecture Documents (SAD). This position requires ASQ Six Sigma Yellow Belt Certification. This position requires a Bachelor’s degree or equivalent in Biomedical Engineering or a related field and 2 years related experience. Must also have 24 months of experience with each of the following: (1) ensuring quality activities are performed in accordance with 21 CFR 820; (2) providing product development oversight for Class II and III medical devices with focus on Design Control, Change Control, Risk Management, Production and Process Controls; (3) conducting and evaluating biological risks for Class III implantable devices; (4) designing and implementing Device Master Record (DMR) features such as Manufacturing Process Instructions (MPI), Bill of Materials (BOM), Lot History Records (LHR), risk analyses including Clinical Hazard Analysis (CHA), Failure Modes and Effects Analysis (FMEAs), etc. and Quality Process Instructions (QPI); and (5) developing objective evidence through data collection and statistical analyses to support customer regulatory submissions and related critical activities such as validations. Must also have ASQ Six Sigma Yellow Belt Certification. Salary: $121,264 to $126,000/year. Full-time, position located in Fremont, CA. Please apply online at https://viantmedical.com/company/careers/.

Requirements

Bachelor’s degree or equivalent in Biomedical Engineering or a related field
2 years related experience
24 months of experience ensuring quality activities are performed in accordance with 21 CFR 820
24 months of experience providing product development oversight for Class II and III medical devices with focus on Design Control, Change Control, Risk Management, Production and Process Controls
24 months of experience conducting and evaluating biological risks for Class III implantable devices
24 months of experience designing and implementing Device Master Record (DMR) features such as Manufacturing Process Instructions (MPI), Bill of Materials (BOM), Lot History Records (LHR), risk analyses including Clinical Hazard Analysis (CHA), Failure Modes and Effects Analysis (FMEAs), etc. and Quality Process Instructions (QPI)
24 months of experience developing objective evidence through data collection and statistical analyses to support customer regulatory submissions and related critical activities such as validations
ASQ Six Sigma Yellow Belt Certification

Responsibilities

independently maintaining compliance, monitoring the effectiveness of, and updating Meraqi’s Quality Management System (QMS) through SOP and QWI updates
planning and executing sterilization validations using ethylene oxide, gamma and e-beam radiation
monitoring ongoing sterilization process effectiveness for Class II and Class III devices through dose audits and cleanroom monitoring
conducting and evaluating biological risks for Class III implantable devices
providing quality input for reprocessing and cleaning validation of reusable medical devices
providing product development oversight for Class II and III medical devices with focus on Design Control, Change Control, Risk Management, Production and Process Controls
leading as a QA representative in design/phase reviews throughout the product development life cycle and providing critical feedback
designing and implementing Device Master Record (DMR) features such as Manufacturing Process Instructions (MPI), Bill of Materials (BOM), Lot History Records (LHR), risk analyses including Clinical Hazard Analysis (CHA), Failure Modes and Effects Analysis (FMEAs), etc. and Quality Process Instructions (QPI)
leading feasibility studies of the design to determine product ability to function as intended
maintaining detailed Design History Files (DHF) of medical devices throughout all phases of the Design Control process
developing, documenting and updating risk analyses through Risk Management Summary Reports (RMSR), Risk Registers, FMEAs and Hazard Analyses (HA)
developing and reviewing verification and validation test protocols and reports
creating, classifying and reviewing equipment for process validation activities such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
independently leading the investigation and closure of Corrective Actions and Preventive Actions (CAPA), and Non-Conforming Material Report (NCMRs)
developing objective evidence through data collection and statistical analyses to support customer regulatory submissions and related critical activities such as validations
ensuring supplier quality systems meet Meraqi Medical, Inc. requirements
leading training sessions of company employees in Quality System procedures and processes
providing software quality assurance, reviewing and approving Software Requirements Specifications (SRS), Software Hazard Analysis and Software Architecture Documents (SAD)