Job Role:
We are seeking a highly skilled Quality Systems Engineer to develop and refine quality system policies and procedures for new product development (NPD).
* This role involves working across various departments to develop and implement global policies and procedures.
* You will be responsible for ensuring that quality system policies and procedures meet the needs of stakeholders and regulatory expectations.
Main Responsibilities:
* To develop and refine Cook Medical Global Design Controls, Process Development, and Risk Management quality system policies and procedures for NPD.
* To work across Global Research and Development, Quality Systems, and functional stakeholders in divisions, units, and operational teams to develop and implement global policies and procedures.
* To support other companies as needed to implement global quality system policies and procedures.
* To represent Cook Medical in internal/external audits and act on assigned audit responses/CAPAs.
* To maintain company culture, values, and commitment to ethics and compliance by recognizing, demonstrating, and enforcing appropriate and compliant behavior.
Requirements:
* Bachelor's Degree required in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines.
* Experience developing and managing policies and procedures.
* At least 5 years' experience working in R&D and/or New Product Development, Process Development/Manufacturing Engineering, R&D systems engineering-Design Controls, Process Development, and/or Risk Management, Quality Assurance/Quality Engineering.