Design Controls Engineer
Develop and refine Cook Medical's global design controls, process development, and risk management quality system policies and procedures for new product development (NPD).
* Ensure quality system policies and procedures meet the needs of stakeholders and the expectations of regulators.
* Interpret standards, regulations, and guidance documents to tailor these needs into systems which meet requirements and offer a usable approach.
* Develop effective solutions capable of meeting global needs.
Key Responsibilities:
Work across Global Research and Development, Cook Medical Quality Systems, and functional stakeholders in the divisions, functional units, and operational units to develop and implement global policies and procedures for Design Controls, Process Development, and Risk Management.
Develop and maintain an understanding of applicable standards, regulations, and guidance documents that affect Design Controls, Process Development, and Risk Management.
Coordinate implementation of global policies and procedures with local sites and Global Research and Development Operations Design Assurance personnel.
Support other Cook companies as needed to implement global quality system policies and procedures.
Represent Cook Medical in internal / external audits and act on assigned audit responses / CAPAs.
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 at least one of the following areas: 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.
Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision. Experience working in a global environment / global teams across many cultures and regions, managing and executing complex projects / programs in an engineering environment. Willingness and availability to travel on company business.