Cook Group

Customer Support

• Process all orders and other customer transactions accurately through relevant company systems within department guidelines and Quality requirements.
• Process all queries within department guidelines through relevant company systems.
• Process product complaints through relevant company systems and within the required timelines.
• Liaise with relevant courier companies and/or relevant internal teams as needed to ensure prompt delivery to all customers.
• Manage urgent and/or emergency orders/requests as they arise and communicate to the relevant teams, manufacturing plants, etc., seeking advice of more experienced colleagues as required.
• Log all internal and external customer feedback correctly and on time, promote the Customer Portal when possible.
• Maintain and update customer data as required.
• Liaise with Cook Medical field-based sales teams, Field-based Inventory team and Supply Chain Operations teams to ensure the fastest possible turnaround on all inventory, inventory returns, and resolution of any inventory issues that may occur.
• Complete all training assigned in a timely manner to ensure required level of competence for this role and to maintain audit compliance.
• Take on additional tasks and involvement in the execution of new departmental projects/initiatives as trained/required.
• Consistently display a positive attitude towards customers and colleagues, treating everyone in a professional manner and with respect.
• Always ensure a high level of customer support to all customers, taking ownership for first point of contact resolution wherever possible.
• Maintain a supportive and communicative relationship within direct and wider teams at all times.
• Carry out all tasks in compliance with the Company’s Quality Management Systems.

Customer Support Representative, French

Engineer

• Contribute technical expertise to research activities in R&D and across the R&D Ecosystem
• Lead large-scale or multiple projects which may span across other R&D teams and/or Ecosystem with a high degree of independence
• Provide technical and strategic input on managing company intellectual property relevant to areas of work
• Understand unmet clinical, market, technology and business needs through application of technical knowledge
• Formulate value propositions for new opportunities for innovation and portfolio expansion
• Assume responsibility for conducting and coordinating research activities, evaluating findings, and formulating evidence-based conclusions
• Communicate and collaborate effectively within the team and with other departments/functions to evaluate new technologies
• Contribute to the continuous improvement of practices and procedures
• Act as a mentor to other personnel within the team; responsible for delegating and reviewing others' work product as part of a project team

Senior Research & Development Engineer – iMRI

Business Operations

• Focus on executing and launching the processes, solutions, and initiatives, once a process is determined and finalized.
• Support ad-hoc process, change management in areas where a need is identified, Commercial Productivity implementation.
• Ensure operational processes are efficient, effective and compliant in meeting the needs of our customers and internal stakeholders.
• Lead efforts to measure and ensure processes are being followed-through and meeting expectations.
• Partner with sales and marketing team(s) in leading and executing the market initiatives.
• Maintain, execute and follow up on operational activities in alignment with division global and regional goals.

Business Operations & Execution Manager, iMRI Division

Project Manager

• Establish EUMDR implementation project plans with associated milestones and deadlines.
• Communicate with stakeholders throughout projects.
• Act as a single point of contact and provide coordination of deliverables.
• Develop strong relationships with all stakeholders to create high-functioning global project teams.
• Ensure that projects are completed on schedule and with appropriate documented approvals.
• Oversee routing, tracking, and archiving of project documentation.
• Identify, document, and facilitate resolution of project risks and issues.
• Provide coaching and guidance to relevant team members in best project practices.
• Develop and review project status reports with relevant team members.
• Follow up on needed changes as required.
• Develop and document resource information and summaries.
• Facilitate project status meetings and other meetings as required.
• Ensure training completed for users on new systems and processes.

Project Manager 1, Regulatory Affairs – Contract

Accountant

• Responsible for accounting, financial statements review & external statutory reporting for multiple legal entities in APAC eg. Singapore, Korea, etc.
• Liaising with external advisors and external auditors from planning to completion of local audits and other ad hoc assignments.
• Working with internal stakeholders
• Responsible for the accuracy of P&L and Balance sheet for your entities.
• Calculate and Post journal entries, inventory reconciliation and close month-end within specified deadlines.
• Analyze P&L for accounting accuracy and reconcile and review balance sheet reconciliations.
• Responsible for generating ideas to drive continuous improvement, enhance standardization of work and implement automation solutions, including AI solutions.
• Build awareness and knowledge of the business and operating environment of the respective legal entities.
• May be required to present information to auditors and other external parties from time to time
• Strong teamwork and collaboration mentality.
• Support tax audits and other business initiatives.
• Manage ad hoc projects, analysis, tasks as required.

Senior Accountant

Human Resources

• Supports the administration of HR policies, procedures, and programs in partnership with the HR Supervisor
• Maintains employee records and HR systems, ensuring accuracy, confidentiality, and compliance with recordkeeping requirements
• Processes HRIS transactions, including new hires, status changes, and terminations
• Assists with onboarding and offboarding processes, including new hire orientation and exit procedures
• Provides support on employee relations matters
• Assists with recruitment activities, including job postings, candidate screening, interview coordination, and pre-employment processes
• Responds to employee inquiries related to HR policies, benefits, payroll, and timekeeping
• Supports benefits administration
• Assists with performance management processes
• Supports leave of absence administration
• Provides support for company events and employee engagement activities
• Coordinates training activities
• Assists with compliance activities
• Prepares HR reports and maintains data for analysis

Human Resources Generalist

Software Engineer

• Follow procedures pertinent to tasks being performed
• Ensure accurate and complete documentation
• Provide support to other team members upon request and where reasonable
• Learn quickly about previous research, project objectives, and project deliverables
• Work with mentor and/or other team members to define tasks
• Coordinate resources to meet project needs and deadlines

Co-op, Sustaining Engineering

• Identify and solve device related material and biocompatibility problems/issues
• Lead and/or assist in material related projects/activities including: Restricted Substances / REACH Evaluation of material related supplier changes
• Material related Corrective and Preventive Actions (CAPAs)
• Product design changes (material and manufacturing processes)
• Biocompatibility
• Contribute technical/scientific expertise in the areas of material design, biocompatibility assessment, failure mode analysis and root cause analysis.
• Responsible for developing, reviewing, understanding, and summarizing material testing and biocompatibility results.
• Ensure personal compliance with Cook values, quality system procedures, policies and relevant medical device standards and regulations.
• Participate in reviews of engineering team outputs (design control and design change deliverables, design reviews and risk evaluation reviews) and contribute to a high quality of output.
• Conduct education/training events and activities for the Engineering team.
• Lead and/or assist in material and biocompatibility related QMS updates.
• Collaborate with Global and Local Functional departments to determine work objective, priorities, deliverables and timelines.

Senior Materials Engineer

QA Engineer

• Understand and review Validation documentation, Change Requests, Design and Process FMEA’s, Software Validation, Microbiological and Sterilisation assessments and Critical System Work Orders.
• Provide Quality Engineering support to the Research and Development, New Product Introduction (NPI) and Sustaining Engineering departments up to and including transfer to Production, understanding Design Assurance activities, reviewing associated documents including Design Inputs, Design Verification/Design Validation, Design and Product transfer, Design and Process FMEA and Process Validation.
• Liaise with Production and Quality Control by providing Quality Engineering support to Incoming Quality Control, In-Process and Final Quality Control.
• Drive the Cook Medical Corrective and Preventive Action program (CAPAs) and the Non-Conforming Product Process.
• Drive field action assessments and support field action.
• Support of the Internal Audit and Regulatory Audit Programmes.
• Represent Quality Engineering in audits.
• Analyse quality data to identify trends, highlight systemic risk, and drive improvement actions
• Initiate, manage and execute projects for continuous improvement within the department.
• Ensure that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
• Provides informal mentoring and technical guidance to QE1s.
• Delegate to the Senior Quality Engineer/ Quality Engineering Team Lead.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Quality Engineer 2 – contract role

• General project management: Supervise projects through the development process, liaise with stakeholders, communicate progress, prioritise tasks, and help to resolve issues or take corrective action as required.
• Change control: Write change orders to create new and/or update existing labelling assets using the electronic change control system. Manage those changes through the various approval stages to final implementation.
• Participate as an SME (subject matter expert) in projects requiring input from a Labeling Assurance perspective.
• Meet all timelines and relevant actions of assigned CAPAs/NCRs and present progress at CAPA assignee meeting and CRB (CAPA Review Board).
• Process improvement projects: Develop new processes where required and optimise current processes within the Cook Medical quality system requirements.
• Layout/design: Work in InDesign software to typeset IFUs, patient-facing information (PFIs), and patient cards that conform to predetermined sizes and standards; work in the company labelling system to design, update, and approve product labels and implant cards.
• Proofread various documents against their source files to ensure accuracy.
• File transfer and management while maintaining strict version control: Manage document files as they move through the process of review, approval, translation, printing, and implementation.
• Liaise with outside vendors (e.g., translation and printing companies), providing them with source files, clarifying any issues or questions, and ensuring their timelines adhere to project schedules.
• Maintenance of data within the company labelling system, including administration of user access and permissions for relevant personnel and monthly archiving of product information.