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Sr QA Validation Specialist

Date: Oct 15, 2021

Location: Pendleton, SC, US, 29670

Company: Arthrex

Requisition ID: 50543 
Title: Sr QA Validation Specialist 
Division: Arthrex Manufacturing Inc (US02) 
Location: Pendleton, SC

 

 

 

 

 

 

 

 

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr QA Validation Specialist works directly with the Arthrex Quality Engineering and Manufacturing  departments within Arthrex This role is responsible for supporting the Arthrex Manufacturing South Carolina Validation Manager with all process validation, related support for the life cycle development, and manufacturing of Class I, II and III medical devices.  Excellent communications and analytical skills, strong technical project management skills, a minimum of five years of applicable experience and a and a Bachelors’ degree will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

This is an in-office position located in Pendleton, SC; it is not a remote position.

 

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

 

Education and Experience:

  • Bachelor’s degree required preferably in an Engineering or Science 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), SAP or similar inventory software and MiniTab.

 

This is an in-office position located in Pendleton, SC; it is not a remote position.

 

 

 

 

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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