Specialist II - Project Engineer

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Purpose of the function/ position and functional area: 

The purpose of this position is to assure that the implementation of the Label Change are being done in a timely manner, safe and effective. 

Responsibilities:

Label Change Coordinator:

• The label Change Coordinator is the contact person in Mexico label changes; when a change starts the label change coordinator will be the leader of the changes having the following responsibilities.
• Start the change CCR process once all the details are given and clarified.
• Properly plan the label changes to meet the required implementation date.
• Coordinate the activities in the label change accordance with the requirements & information given.
• Responsible for the creation/modification of the packaging specifications, assuring that they are always updated accordingly.
• Responsible for the address list that shall always be updated.
• Responsible for assigning CR ID number and evidence of the same in the corresponding folder / drive for Artwork & Labeling Team DK / MX.
• Participate in Artwork & Labeling Team.
• Participate in approval of artwork and run-in test.
• Be involved in Major Changes activities.
• Train persons being involved.
• Support testing of new items, tests in Code Soft System.
• Control artwork files.
• Continue as step revision of the open changes.
• Assure proper implementation of the change.
• Maintain documentation of the change.
• Bring a continuous communication with the different departments for the proper and timely implementation of the change.

Interfaces:

• Label Change Coordinator must communicate with:
• Artwork & Labeling Team DK/MX
• Production MX
• Logistics DK/MX
• Sales & Marketing DK
• QA/QC DK/MX
• Customers

Projects support

• In addition, the label changes coordinator is also a support to the local manager
• Create new templates for test

Product analysing:

• Work together with quality those criteria that are not defined for the resolution of visual problems.
• Rejections in the projects inspections which cause is not known.
• A Trend in claims.
• In general, it is expected that this position will help in general to improve the production processes at any time.

General Activities

• Support the Project manager in the requirements of the Quality Assurance System based on ISO 13485 and FDA CGMP regulations.
• Responsible for the creation of procedures, instructions and forms applicable for the position.
• Maintenance and safe keeping of records applicable for the position in accordance to the good documentation practices.
• To comply with the company quality policy.
• To follow, develop and acting according to Quality Assurance System based on ISO 13485 and FDA CGMP regulations.

Powers:

• The label change associate is empowered to propose changes in the label changes system as action of continuous improvement to the Artwork & Labeling Team Manager.
• Generate CAPAS on nonconformities found.
• Propose recommendations to the Project Manager.

Safety, Health and Environmental Responsibilities

• 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 – international

• Effective implementation of the label changes.
• Detailed revision of the documents (label specifications, address lists, others) that are involved in the proper implementation of label change.
• Effective coordination of the label changes.

Demands for education, training and competence – international

Job profile

• Min. 2 years work experience in projects (manufacture, improvement, quality, etc)
• Fluent verbal and written English (required).
• Experience in project management, be part of a project, SME.
• Familiar with the use of computer software.
• Building productive relationships with design teams (such as: branding, human factor, marketing) and external parties (customers, agencies, print houses).
• Induction 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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Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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