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|Quality Assurance Engineer II - Walnut|
|Hours:||40 Monday to Friday 800am to 500pm|
|Pay:||DEPENDS ON EXP|
|Great Opportunity Available in City of Industry|
We are seeking a self-motivated Quality Assurance Engineer II to ensure the highest quality of surgical hand instruments. Responsible for supporting the Quality Manager and the Quality Department group with all quality-related document control functions, new product development of Class I medical devices, continuous improvement, and other QMS functions. Responsible for participating in design and development projects and assuring the design process meets all requirements. Maintains applicable portions of the design history file for assigned projects, adhering to design control procedures. Supports other engineering activities, including analysis, test execution, evaluation, and other functions. Provides critical review, approval, modification, and feedback of the ECO process, ensuring that engineering changes are complete, accurate and properly documented. Assists production, design, and manufacturing engineering in assessing new manufacturing technologies and requirements for quality input. Responsible for writing andor assisting in the writing of validations, work instructions, and test reports. Initiates CAPA and QMS related documentation as required by procedures. Assists in the creation, investigation, and disposition of nonconforming product. Supports production related processes and issues, including rework, troubleshooting, quality inputs, and resolutions. Works with suppliers to improve quality and assists with product related issues. Assists in complaint investigations related to product quality. Assists the Service and Repair Department in evaluating complaints, including review of DHRs and other supporting roles. Assists in training QC Inspectors on inspection techniques and the use of new equipment, including developing methods and tooling for test and inspection. Participates in Internal and External quality audits as directed by the Quality Assurance Manager.
BA Degree in Engineering or Science. 3 yrs exp in Quality ControlAssurance, preferably in a medical device company. Exp w testing equipment, statistical methods, control plans, validation principles, design controls, manufacturing quality, CAPA.
Experience in the medical device industry or ISO regulated environments preferred. Working knowledge of process improvement tools i.e. Lean - PDCA, Six Sigma - DMAIC and problem solving i.e. Kepner Tregoe, Lean A3, 5 Whys preferred.