Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com

 

Purpose of the function/position and functional area – international

Have a position responsible for:

Assure the supplier quality and supplier performance providing to the supplier the adequate level of understanding  of the quality expectations and applicable regulatory requirements.Development of suppliers and ensure they are properly qualified.Work in close collaboration with Category Managers, Mold Team, R&D, QA and Operations in Denmark and Mexico.Make sure supplier audit plan is fulfilled.

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Responsibilities.

Development of the supplier quality system by:Participate in the supplier audits for new and existing suppliers as per schedule and the appropriate level of documentation as per procedure.Handle the non-conformities/SCARs and Corrective/Preventive actions when escalated, on timely manner.Participate on Supplier Quality Reviews in collaboration with Category ManagersActive participation on Material Review Boards (MRB)Participate on the approval of new suppliers as per procedure.Assure the supplier evaluation are performed and take actions accordingly.Responsible for immediate communication and the follow up on final disposition of raw material (no conformance,  acceptable materials, etc.) in adequate time and according with approved procedures.Participate on root cause analysis, NC reviews, analysis of FMECA's, coordinate investigations, etc. if required.Manage QA/QC related activities in relation to new and existing tools approval processes. Drive continuous improvements in relation to total cost ownership, speed, optimization etc by use of known LEAN techniques in collaboration with supplier and stakeholders. Actively participate in various new product development, product transfer and other optimization projects Promote teamwork among his area, and other areas.To comply with the company quality policy.Follow up, development, and compliance according to the Quality Management System based on the regulations  and standards of ISO 13485, FDA, GMP, MDR.To submit changes of the evaluates processed if improvements are able to make.To submit Corrective or Preventive actions to solve problems related to supplier quality processes or systems.To submit recommendations on aspects where can be risk on the quality of the product and/or systems. Use QA System to make constant improvements in products, processes and systems to reduce cost of failures and  meet customer requirements.Stop machinery operation, activities or processes that can affect the quality of the product or quality system.Comply with safety, health and environmental policy, procedures established by the EHSMS. Maintain applicable documented information related to the EHSMS up to date. Participate in committees, trainings, and awareness, to ensure proper competency of their position if applicable. Be aware of and support compliance with applicable significant environmental aspects and associated significant 
environmental impacts. Understand EHS risk and legal requirements relating to job responsibilities and appropriate requirements. Execute job responsibilities with professional care and in compliance with legal requirements and internal standards 
without compromising the safety of self and others. Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to 
responsible management as soon as they are identified (e.g. spills). Help drive continuous performance improvement in EHS areas, recommending potential improvements to responsible management. Participate in identifying opportunities for improvement and implementing the necessary actions to achieve the  intended results of their activities.

Success criteria

Excellent communication with relevant areas to develop suppliers and improve supplier quality (between DK/MX)Improve quality of materials through the development of suppliersKeep fulfilment with requirements and internal proceduresApproval for new components and suppliers are done without negative effects to company goalsContribute to Operational Quality Objectives are achieved

Demands for education, training and competence

Bachelor’s degree (Industrial area or similar), requiredThree years as Supplier Quality areas experience, preferredMeasurement equipment knowledge skill preferred.Written and spoken English requiredInternal Auditor requiredExperience of quality tools, statistic techniques (SPC, etc.) preferredSoftware utilization skills / Computer skills requiredAbility to coordinate multiple projects, projects planning and work cohesively with all involved departmentsGeneral knowledge of injection molding processes preferred.Familiar/knowledge on ISO 2859-1 (AQL values and sampling plan) Familiar/knowledge on basic requirements of FDA QSR's GMP's and ISO 13485, MDR or similar regulations, required.Internal trainingCompliance with document 4902900Induction to ISO 14001:2015. Induction on Environmental Legal Requirements, Training on Applicable Environmental Management System Documents, Disaster Care and Response, Applicable Operational Controls, Determination of Applicable Significant Environmental Aspects and Impacts, EHS Policy and Environmental Objectives.

 

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