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Sr QA Validation Engineer - Manufacturing

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Clemson, SC
Job Type
Direct Hire
Mar 03, 2019
Job ID
Sr QA Validation Engineer - Manufacturing
Summary Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Main Objective:
Responsible for supporting the 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 company 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 in Engineering or Engineering Technology required.  At least seven 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.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.
Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:
Phil Montoya
Director of Sourcing
3735 SW 8th Street, Suite 205
Miami, FL 33134
P: 832-266-1610
Fax: 305-520-0138
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