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Quality Assurance Engineer

Company: N/A

Location: Ave Maria, FL

Pay: N/A

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Job Description

Requisition ID: 33301 Title: Quality Assurance Engineer Division: Arthrex Manufacturing Inc (US02) Location: AMI East- AMI- Ave Maria, FL (US05)

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:

  1. Responsible for participating in design and development projects and assuring the design process meets all requirements.
  2. Maintains applicable portions of the design history file for assigned projects, adhering to Arthrex design control procedures.
  3. Supports other engineering activities, including analysis, test execution, evaluation, and other functions.
  4. Provides critical review, approval, modification, and feedback of the ECO process, ensuring that engineering changes are complete, accurate and properly documented.
  5. Assists production, design, and manufacturing engineering in assessing new manufacturing technologies and requirements for quality input.
  6. Responsible for writing and/or assisting in the writing of validations, work instructions, and test reports.
  7. Initiates CAPA and QMS related documentation as required by Arthrex procedures.
  8. Assists in the creation, investigation, and disposition of nonconforming product.
  9. Supports production related processes and issues, including rework, troubleshooting, quality inputs, and resolutions.
  10. Works with suppliers to improve quality and assists with product related issues.
  11. 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.
  12. Assists in training QC Inspectors on inspection techniques and the use of new equipment, including developing methods and tooling for test and inspection.
  13. 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).


Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.


Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. 


Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures.


Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 



Vision Requirements:

Visual acuity necessary to do the job safely and effectively. 

Specific vision abilities required by this job include close vision using a microscope and light source.


Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

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.


Job Requirements