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Quality Assurance Engineer II - ACI

Company: Arthrex, Inc.
Location: Walnut
Posted on: June 12, 2021

Job Description:

Requisition ID: 47598 Title: Quality Assurance Engineer II - ACI Division: Arthrex California Inc (US03) Location: Walnut, Ca

We are seeking a self-motivated Quality Assurance Engineer II to ensure the highest quality of surgical hand instruments. The ideal candidate is collaborative and enjoys conducting root cause analysis. Experience in the medical device industry or ISO regulated environments preferred. There is a possiblity that this position will last until June of 2022.

You will be joining a talented team passionate about quality and dedicated to making a worldwide impact by Helping Surgeons Treat Their Patients Better!

Benefits! Temporary employees are eligible for 100% paid medical coverage after the completion of 90 days of service. In addition, we provide all employees with free catered lunches Monday through Thursday.

Main Objective: 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.

Essential Duties and Responsibilities:

  • 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 Arthrex 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 and/or assisting in the writing of validations, work instructions, and test reports.
  • Initiates CAPA and QMS related documentation as required by Arthrex 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 DHR's 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.

Education and Experience:

  • Bachelor's degree required; preferably in an Engineering or Science discipline.
  • 3 years experience in a Quality Control or Quality Assurance position in a Medical Device Company preferred.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Knowledge of testing equipment, statistical methods, control plans, validation principles, design controls, manufacturing quality, root cause analysis, CAPA.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: Arthrex, Inc., Los Angeles , Quality Assurance Engineer II - ACI, Other , Walnut, California

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