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Quality Assurance Engineer II - Medical Devices in City of Industry, CA , at Arthrex
Quality Assurance Engineer II - Medical Devices
Arthrex California Inc
City of Industry, 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.
You will be joining a talented team passionate about quality and dedicated to making a worldwide impact by Helping Surgeons Treat Their Patients Better™!
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.
Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience: Bachelor’s degree required preferably in an Engineering or Science discipline. At least three 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.
Machine, Tools, and/or Equipment Skills: Proficient in the use of computer and computer programs, such as: Microsoft Office, PLM, and ERP systems (preferably Agile, SAP).
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.