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Sr Design Assurance Engineer in Naples, FL ,  at Arthrex

Date Posted: 5/28/2018

Job Snapshot

  • Employee Type:
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Requisition ID:
Sr Design Assurance Engineer
Arthrex, Inc.
INC- Naples, FL

Main Objective:

Responsible for supporting the Quality Manager with all quality related  support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products.

Essential Duties and Responsibilities:

  1. Responsible for participating in design and development projects and assuring the design process meets all requirements
  2. Responsible for reviewing design drawings for tolerance, inspect-ability and quality of design issues
  3. Work with suppliers to improve quality and assist, where necessary, in supplier process validations
  4. Train and/or assist QC Manager in the training of QC Inspectors on inspection techniques and the use of new equipment
  5. Participate in Internal and External quality audits as directed by the Quality Assurance Manager
  6. Responsible for assisting in the design and development of methods and tooling for the test and inspection of articles
  7. Responsible for assisting in maintaining vendor files in accordance with established procedures and SOPs
  8. Responsible for writing and/or assisting in the writing of test and inspection SOPs
  9. Responsible for assisting in complaint investigations as related to product quality
  10. Responsible for assisting in compiling and reporting on Vendor performance statistics
  11. Responsible for filling in for absent QC technicians and the Document Control Specialist as directed by the QA Manager
  12. 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 Science discipline.  At least seven years’ experience in a Quality Control or Quality Assurance position required, preferably in a Medical Device Company.

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.

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.