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Senior Engineer I - QA Validation

Date: Sep 10, 2021

Location: Pendleton, SC, US, 29670

Company: Arthrex

Requisition ID: 49505 
Title: Engineer Sr I - QA Validation 
Division: Arthrex Manufacturing Inc (US02) 
Location: Pendleton, SC 

 

 

 

 

 

 

 

 

 

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. Arthrex is actively searching for a Senior Quality Assurance Validation Engineer. A minimum of five years of applicable experience and a Bachelor’s degree are essential for this position. Ideal candidates will have previous medical device experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

 

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:

  1. Provide daily direction and technical support to validation engineering staff
  2. Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.
  3. Responsible for reviewing and approving validations of special processes performed at all Arthrex facilities
  4. Encourages a continuous process improvement environment
  5. Recognizes and addresses process problems regularly
  6. Interviews staff, oversees staff training, and responsible for staff development
  7. Recommends proper staffing levels based on validation needs
  8. 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 or Engineering Technology discipline. 
  • 5 years of Process Validation work experience required, preferably within a Medical Device Company. 

 

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

Knowledge of testing equipment, statistical methods, control plans.

Knowledge of cGMP and GDP requirements.

 

 

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 and MiniTab.

 

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.


Nearest Major Market: Greenville
Nearest Secondary Market: South Carolina

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