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Job Type
Direct Hire
Jun 14, 2017
Job ID
This position requires a Bachelor's Degree and at least three years of experience in QA/QC, preferably in medical device manufacturing. 
ASQ CQE certification, ISO 13485 auditing experience, Lean/6σ experience and clean room experience with assembly/packaging would all be highly desired. 
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
 Education and Experience:
Bachelor’s Degree required, preferably in an Engineering or Science discipline.  At least three 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), SAP or similar inventory software.
 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.