Develop and refine Cook Medical 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, in particular:
• Ensure the policies and procedures are compliant with applicable standards, regulations, and guidance documents.
• Interpret standards, regulations, and guidance documents to tailor these needs into systems which meet requirements and offer a usable approach for Cook Medical.
• Develop effective solutions capable of meeting global needs.
• Develop systems which can be operated effectively by personnel and build usability into the processes to drive robust product designs and manufacturing processes.
Reporting to: Manager, Global R&D Operations – Quality Processes & Design Assurance
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- Work across Global R&D, 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 affect Design Controls, Process Development, and Risk Management.
- Coordinate implementation of global policies and procedures with local sites and Global R&D 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. Monitor Design Controls, Process Development, and Risk Management CAPAs and internal / external audit feedback from the manufacturing operations entities' quality systems and evaluate impacts to Cook Medical’s global policies and procedures.
- Participate in the development and deployment of training:
Develop training materials and visual aids to support procedures and policies, using smart approaches with worked examples.
Coordinate and conduct training with users globally on quality system policies and procedures.
Drive consistency across Cook Medical in the approaches to Design Controls, Process Development, and Risk Management
- Maintain our culture, values and commitment to ethics and compliance by recognising, demonstrating, and enforcing appropriate and compliant behaviour.
- Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards, including Cook policies.
- Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.
- Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
- Bachelors 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
- Effective oral and written communication skills.
- 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.