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

About the role

The Quality Assurance Engineer will have a key position to support production as main leader, assuring the compliance for regulations, standards, QMS internal procedures on new projects, process improvements, validation & re-validations, risk management and customer complaints investigations.

In relation to quality issues from nonconforming material, maintain quality indicators and internal deviations to coordinate and perform needed activities for a good follow up of a quality system.

Key responsibilities

Process Control related

• Assure the process control is followed during product manufacturing. Monitor the process output and organize activities to meet and maintain the product quality standards.
• Support the quality system by being focused on adequate handling of non-conformity activities, corrective and preventive actions.
• Define a classification of all Non-Conformities based upon the risk.
• Coordinate and lead the investigation / root cause, with the team member involved (maintenance, production, logistic, engineering, etc.).
• Review, update and develop procedures, instructions, quality specification as needed.
• Collect and review the objective evidence to complete the investigation and therefore the correct NC closure and assure the effectiveness of the actions established.
• Follow up the QA roll as per NC procedure require (for instance, Originator, Owner, Quality Reviewer, Approver, etc.) as needed.
• Monitor the process KPIs (PPMs, NCs, etc) and present any trending to the NCRB and take actions if needed.
• Make sure the actions are being supported or referenced to the quality system.
• Promote ideas for continuously improvement of Quality with the end achieve the fulfillment across of the systems simplicity.
• Support at several areas where his/her experience and technical knowledge about the problem can be usefully (production, microbiology, systems, etc).
• Perform internal process audits, when required.
• Keep communication with other departments MX / DK in relation to any quality problem.
• Create Quality alerts and Provide support on the definition of quality criteria, when needed.

Projects & Validation related

• Participate in development teams having as main responsibility the quality and fulfillment with the regulations or other applicable standards.
• Update and develop PFMEcA from the Risk management related with changes from projects, internal inputs, etc.
• Support on the risk assessment preparation, when needed.
• Support on the development of verification and validation of products.
• Establish and maintain VMP (Validation Master Plan) for re-validation of process equipment, including validation history and assure it is approved by and communicated to relevant areas.
• In cooperation with the Production and Eng Department ensure resource planning for re-validation activities.
• Filling of validation documentation is following procedures and applicable regulations.
• Review of acute maintenance on process equipment for evaluation of need for re-validation according to document 4705007.
• Management of software validations in all systems applied, in collaboration with project leader
• Collaborate on validation of molds and molding machines providing the support as Quality Engineering
• To comply with the company quality policy.
• Support on review IQ, OQ and PQ validations of test equipment validation.

Safety, Health, and Environment 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, training's, 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.

Requirements

• Bachelor's degree (Mechanical, Electronic, Industrial area or similar education)
• Min. 3 years' experience on Engineering areas
• Strong Experience on handling of QMS (Quality management system)
• Strong Experience on Quality Control Charts (histogram, pareto, process capability calculations, controls charts, etc)
• Strong Experience on Quality Management Tools (brainstorms, flow diagrams, cause and effect diagrams, etc.)
• Focus on continues improvement mindset
• Verbal and written English, C1 level minimum
• Training/Knowledge on FDA QSR's and GMP's, ISO 13485, J-PAL/Ordinance No.169, EU and Canadian medical devices regulation, or similar regulations, preferred
• Familiar with common computers software packages. MS Office, etc. required
• Availability to work in different shifts.
• Molding process knowledge
• Able to travel, if required

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Equal opportunities

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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