Maintain and refine Cook Incorporated Design Controls quality system policies and procedures, ensuring that they meet the needs of stakeholders and the expectations of regulators. Additionally, provide guidance to Manufacturing and Post-Market Engineering and other departments that interface with Design Controls activities.
• Work with Manufacturing and Post-Market Engineering, Risk Management, and other stakeholders to maintain and refine policies and procedures for Design Controls.
• Develop and maintain an understanding of applicable standards, regulations, and guidance documents that affect Design Controls.
• Help support Cook Incorporated in internal / external audits and assist with audit responses / CAPAs. Monitor Design Controls CAPAs and internal / external audit feedback from the manufacturing operations quality systems and evaluate impacts to policies and procedures
• Participate in the development and deployment of training
• Coordinate and conduct training
• Drive consistency across Cook Incorporated in the approach to Design Controls.
• Within scope of responsibility, ensure all quality, regulatory, compliance, and product-specific requirements are met.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Must strictly adhere to safety requirements.
• Maintain regular and punctual attendance.
• Must maintain company quality and quantity standards.
• Must have effective communication skills, which may include oral or written
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal
• Ability to remain calm and receptive in fast paced situations.
* BS in Engineering, preferably in Mechanical or Biomedical.
* Minimum 2 years experience in the Medical Device Industry, preferably with Cook.
* Experience in developing and managing policies and procedures is preferred, but not required.
Works under general office environment conditions
Utilizes close visual acuity for working with computers and equipment
Frequently required to stand, walk, and hear
Occasionally required to lift up to 20 pounds