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Senior Design Control Engineer-Risk Management

Company: Cook Medical
Location: Bloomington
Posted on: June 12, 2021

Job Description:

Senior Design Control Engineer-Risk Management Posting Date 7 months ago (11/9/2020 9:56 PM) Requisition ID 2020-8119 Job Location(s) Bloomington IN United States Travel Less than 10% Shift Type First Position Type Full Time Company Cook Medical Inc. Category Engineering Overview Primarily invovled with risk management systems, the Senior Design Control Engineer at Cook Medical will 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 Responsibilities Work across Global R, 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 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 Qualifications College degree in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines is preferred Experience developing and managing policies and procedures Experience working in at least one of the following areas: - R and/or new product development - Process Development / Manufacturing Engineering - R 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 environmentPhysical Requirements: Must be able to perform the essential functions of the job, with or without reasonable accommodations Approximately 90% of the time is spent in a normal office environment requiring sitting and moving around the building Approximately 10% of time is spent in domestic/international travel to various locations to support project activities Collaborate with peers and Managers regularly through on-line communication methods at times during and outside of normal working hours being flexible in accommodating these demandsOptions Apply for this job online Apply Share Share the job posting with a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.Share on your newsfeed"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.

Keywords: Cook Medical, Bloomington , Senior Design Control Engineer-Risk Management, Other , Bloomington, Indiana

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