Quality Assurance Engineer II - ACI
Company: Arthrex, Inc.
Posted on: June 12, 2021
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
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
- Maintains applicable portions of the design history file for
assigned projects, adhering to Arthrex design control
- 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
- 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
- Assists in the creation, investigation, and disposition of
- 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
- 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
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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