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Associate QA Engineer Validation in Ave Maria, FL ,  at Arthrex

Date Posted: 1/25/2018

Job Snapshot

Job Description


Requisition ID:
40223
Title:
Associate QA Engineer Validation
Division:
Arthrex Manufacturing Inc
Location:
AMI East- AMI- Ave Maria, FL

This position will be located at the Arthrex manufacturing facility in Ave Maria, FL.

Main Objective:

Responsible for supporting the AMI Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices.

Essential Duties and Responsibilities:

  • Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
  • Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
  • Other duties as assigned

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, Science or Technology discipline.

Experience in a Quality Control, Quality Assurance or Validation position in a Medical Device Company preferred.

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

Knowledge of testing equipment, statistical methods, control plans.

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software.

Reasoning Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardizations exist. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Mathematical Skills:

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

Language 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. 

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.