Job Title: Senior Design Control Specialist
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About the Role: We are seeking a highly skilled and experienced Senior Design Control Specialist to join our team. The successful candidate will be responsible for developing and refining global design controls, process development, and risk management quality system policies and procedures.
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Main Responsibilities:
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* Develop and refine Cook Medical Global Design Controls, Process Development, and Risk Management quality system policies and procedures;
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* Ensure quality system policies and procedures meet the needs of stakeholders and the expectations of regulators;
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* Interpret standards, regulations, and guidance documents to tailor these needs into systems which meet requirements;
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* Develop effective solutions capable of meeting global needs;
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* Work across Global Research and Development, Cook Medical Quality Systems, and functional stakeholders in the divisions, functional units, and operational units;
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* Develop and maintain an understanding of applicable standards, regulations, and guidance documents affect Design Controls, Process Development, and Risk Management;
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* Coordinate implementation of global policies and procedures with local sites and Global Research and Development Operations Design Assurance personnel;
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* Support other companies as needed to implement global quality system policies and procedures;
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* Represent Cook Medical in internal / external audits and act on assigned audit responses / CAPAs;
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* Monitor Design Controls, Process Development, and Risk Management CAPAs and internal / external audit feedback from the manufacturing operations entities' quality systems;
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* Evaluate impacts to Cook Medical's global policies and procedures;
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* Participate in the development and deployment of training;
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* Develop training materials and visual aids to support procedures and policies;
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* Coordinate and conduct training with users globally on quality system policies and procedures;
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* Drive consistency across the approaches to Design Controls, Process Development, and Risk Management;
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Requirements:
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* Bachelors Degree required in Engineering or Science, preferably in Mechanical, Chemical, Manufacturing or Biomedical disciplines;
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* 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;
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* Excellent oral and written communication skills;
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* Problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision;
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* Experience working in a global environment / global teams across many cultures and regions, managing and executing complex projects / programs in an engineering environment;
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* Willingness and availability to travel on company business;
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We Offer:
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* An opportunity to work with a leading medical device company;
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* A competitive salary and benefits package;
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* Ongoing training and professional development opportunities;
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* A dynamic and supportive work environment;
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To Apply: Please submit your application through our careers page.
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Contact Information: For more information about this role, please contact us at [insert contact information].