Cook Medical | Quality Engineer 2

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation qualification...

Overview The Manufacturing Engineer 2 (Test Method Validation) performs and documents validations of medical device manufacturing processes. Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. Validate and implement medical device manufacturing...

Overview The Manufacturing Engineer 2, New Product Introduction will be responsible for key activities within New Product Introduction. Key activities will include leading projects to either introduce new products or support and improve existing products. More specific details are listed below. Reporting to: Manager, Manufacturing Engineering...

Overview The Senior Manufacturing Engineer (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities Develop and execute Test Method Validations for Test Equipment per current QMS/Regulataory standards. Validate and implement medical device manufacturing processes as assigned. Identify equipment/fixture installation...

Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company’s corrective and preventive...

Overview The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the...

Overview Work as part of the Quality Engineering to provide an efficient service to our customers internally and externally in dealing with product complaints issues and other relevant quality assurance projects as they arise. Reporting to: Team Lead, Quality Engineering Department: Complaints Responsibilities Department:...

Overview The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices , specifically providing oversight in method development and validation, compendial method verification and transfer , specification/acceptance...

Overview The primary purpose of this position is to provide technical support to Production, Manufacturing Engineering and Research & Development. In addition, drive process improvements to increase Manufacturing efficiency plus further develop manufacturing activities within the plant. Reporting to: Manager, Manufacturing Engineering ...

Overview The primary function of this position is to lead and/or participate in projects focused on design modifications of devices post release to market, for the purpose of maintaining device quality and compliance, as well as reducing costs and increasing yields. Reporting to: Team Lead, Post Market Engineering Responsibilities Lead or...

Overview ​​ The Manufacturing Engineering Specialist is responsible for the preventative maintenance schedule of equipment used in production and engineering. This also includes maintaining a database and all related documentation.​ Reporting to: Manager, Manufacturing Engineering Responsibilities ​​Maintain and implement the...

Overview The primary function is to assist in the manufacturing & shipment of medical device products. Reporting to: Supervisor, Production Responsibilities Carry out any process steps required for the manufacture & shipment of high quality medical devices products. Adherence to COOK Quality system procedures and all associated...

Overview The Tender Representative 1 is responsible for working with Cook Medical Divisions & other relevant departments within Cook, to ensure that Tenders to supply Cook Medical products to the European Market are submitted in a timely and accurate manner. This role is also responsible for ensuring Cook Medical product pricing is updated on the...

Overview The Customer Support Representative 1 is responsible for providing a professional, friendly, and efficient service to Cook Medical customers and Divisional Sales teams throughout EMEA. Key tasks include handling customer orders accurately and within agreed service levels, while also providing timely and informative responses to customer...

Overview The Customer Support Representative 1 is responsible for providing a professional, friendly, and efficient service to Cook Medical customers and Divisional Sales teams throughout EMEA. Key tasks include handling customer orders accurately and within agreed service levels, while also providing timely and informative responses to customer...

Overview Hybrid based near Bloomington, IN preferred. Qualified applicants hybrid-based near another Cook facility, or remote based in other locations will also be considered. Responsible for development and ensuring delivery of educational content for product management employees, in alignment with divisions’ mission, vision and purpose,...

Overview The primary purpose of this position is to manage and support Access Technology product lines. Including creating strategies for market development and growth in the region, creating sales concepts to increase market share etc. while working closely with the marketing teams, business management and divisional support in each local market. As...

Overview To proactively promote a positive Environmental, Health and Safety environment for all employees.The Environmental Health and Safety Specialist will provide technical support on occupational safety,ergonomic issues and other relevant environmental, health and safety issues.Job Title: Environmental, Health and Safety Specialist Reporting to:...

Overview Digital marketing supports customer journeys through data-driven channel strategies, demand generation and automated marketing. The Senior Manager, Web Solutions (Owner) owns the vision, strategy, and roadmap for our web channel. They advocate for the web team within Cook, foster collaboration with cross-functional teams, and align web...