**About Convatec**
**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 .
- 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**:
- ** Verbal and written English,**C1 level minimum a MUST**:
- ** CQE (Certified Quality Engineer by ASQ)**a MUST**:
- ** Experience in Cost Reduction projects**a MUST**:
- Black Belt certification
- Bachelor’s degree (Mechanical, Electronic, Industrial area or similar education)
- Min. 3 years’ experience on Engineering areas
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📌 Quality Assurance Engineer (Del Norte)
🏢 Covantec
📍 Del Norte