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Quality Engineer
Ref No.: 18-54647
Location: Salt Lake City, Utah
Position Type:Direct Placement
Start Date: 07/31/2018

Mandatory Skills:
 
·         Product sustenance / product Quality experience
·         Manufacturing process knowledge
·         Knowledge on standards and regulatory requirements for various regions
·         Minitab
·         Device Labelling and use of Symbols
·         Disposable device development
·         Change control Management
·         NC/CAPA
·         Design verification
·         Process Validation
·         DHF Preparation
·         European Requirements (EU MDR)
·         Risk Management
·         ISO 13485 / FDA Guidelines
·         GD&T
·         Prototyping
·         Communication
 
Desired Skills: Advanced Product Quality Planning (APQP)/Quality Engineering & Management (SA), Coordination, In Process Quality & Defect Prevention
 
Responsibilities:
 
·         Independently determines and develops approach to solutions.
·         Contributes to a project of considerable significance or leads smaller scope projects.
·         Supports material/design/process changes to the product line through design control process, with well-documented research/analyses. Demonstrates accountability for successful and timely completion of designated tasks.
·         Should be familiar about medical device standards and develop technical solutions to complex problems using sound engineering principles,
·         Utilizing experimental, computational and analytical methods.
·         Responsible for being the Quality Representative on projects ensuring Design Control requirements are completely meeting internal procedures and external standards.
·         Responsible for reviewing and working cross functions to complete various quality artifacts.
·         Responsible for reviewing and completing documentation related to Non-Conformances found internally and/or externally.
·         Responsible for providing risk assessment & data analysis and result of data.
·         Collects, records, reports, interprets and analyzes data, presents results to peers and business leadership.
·         Develops solutions to routine assigned activities of moderate scope & complexity.
·         Follows applicable Company / Unit procedures and may make updates to procedures and policies.
·         Should have good communication skill, Must have to regularly interact with client and Offshore team