Key Role Summary:
We seek an exceptional engineer to develop and refine global quality system policies and procedures. This individual will work closely with stakeholders and regulators to tailor the needs of Cook Medical.
Main Responsibilities:
* Stay up-to-date on applicable standards, regulations, and guidance documents affecting Design Controls, Process Development, and Risk Management.
* Collaborate with global teams to develop and implement global policies and procedures.
* Coordinate implementation of global policies and procedures with local sites and operations design assurance personnel.
* Promote internal/external audits and act on assigned audit responses/CAPAs.
* Maintain our culture, values, and commitment to ethics and compliance by recognizing and enforcing appropriate behavior.
Requirements:
* Bachelor's Degree in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing, or Biomedical disciplines.
* At least 5 years' experience working in R&D and/or New Product Development, Process Development/Manufacturing Engineering, systems engineering-Design Controls, Process Development, and/or Risk Management, Quality Assurance/Quality Engineering.
* Effective oral and written communication skills.
* Excellent problem-solving skills and ability to work independently with minimal supervision.