Quality Specialist

Posting Date 1 month ago(5/4/2021 3:19 PM)
Requisition ID
Job Location(s)
West Lafayette IN United States
Shift Type
Position Type
Full Time
Cook Advanced Technologies


This person is responsible for assuring that the quality policy and quality system are understood, effectively implemented, and maintained at all levels of the organization.



  • Develop and refine QMS documents by developing procedures, guidance documents, forms, training materials, and other documentation
  • Ensure QMS processes are compliant with pertinent regulations and external standards
  • Maintain a working knowledge of QMS procedures, regulations, and standards
  • Train staff on QMS processes
  • Ensure compliance to Quality Management System (QMS) processes
  • Interact with colleagues at all levels with the goal of researching, problem-solving and coordinating QMS activities to ensure the quality system is effectively implemented
  • Perform QA and QC responsibilities outlined in the QMS (e.g., review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy and compliance to applicable procedural standards and work instructions)
  • Assess impact of proposed procedural changes to QMS and other QMS documents
  • Assist with the performance of internal, external and supplier audits throughout the entire audit lifecycle


  • Technically qualified by education, training and/or experience
  • Minimum of B.S. degree, preferably in engineering or science, 3 years of relevant medical device quality system experience preferred or a combination of education and experience
  • Ability to work effectively within a team and discern how the quality system can help staff reach project goals; understand the goals of Quality System users
  • Excellent communication skills to communicate effectively with professionals from a wide range of backgrounds and education levels
  • Computer skills including word processing and spreadsheets
  • Ability to present information in a professional manner
  • Conscientious person with good work ethic
  • Able to work independently or in a group environment
  • Ability to work with multiple persons, changing priorities and fluctuations in work load
  • Excellent organizational skills and prioritizing skills
  • Experienced or trained in auditing techniques, including successful completion of an internal auditing course


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