Process Quality Engineer

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

Job Summary

Key position to support to production UMD MX as main leader assuring the compliance for regulations, standards, QMS
internal procedures on a New Project (CCR), Process Improvements (OFI), Validation & Revalidations, Risk
Management, Customer complaints investigations. In relation to quality issues from non-conforming material, maintain
quality indicators and internal deviations to coordinate and perform needed activities for a good follow up of a quality
system.

Duties and 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 focus 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, intenal 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 revalidation 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 revalidation activities.
• Filling of validation documentation is following procedures and applicable regulations.
• Review of acute maintenance on process equipment for evaluation of need for revalidation 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.

EHS

• To meet the safety, health and environmental policy.
• To Keep information with respect the Convatec EHS policy and the regulations that support it.
• To understand the risks in EHS and the legal requirements relative with the labor responsibilities and the appropriate controls that apply to manage the risks and requirements.
• To execute the labor responsibilities with professional attention and to fulfill with legal requirements and the internal rules without compromise the own safety and that the others.
• To be aware of the risk on the workstation, reacting to them in proper way and communicate them responsible manager as soon as they are identified (as spilling, etc.)
• To participate in committees, training and awareness, if apply.
• To support on the constant improvement on the EHS areas, doing recommendations on improvements to the responsible manager.

Powers:

• Submit changes of transferred process if improvements can make.
• Submit corrective or preventive actions to solve problems related to quality process or systems.
• Reject plans or submit recommendations on aspects where risk on the quality of the product and/or system can be.
• Call and carry out projects, investigation meetings when needed.
• Stop machinery operation, activities or processes that can affect the quality of the product or quality system.

Required Experience / Technical Background:

• Bachelor’s degree (Mechanical, Electronic, Industrial area or similar education) required
• Min. 3 years’ experience on Engineering areas, required
• Strong Experience on handling of QMS (Quality management system), required
• Strong Experience on Quality Control Charts (histogram, pareto, process capability calculations, controls charts,
  etc), required
• Strong Experience on Quality Management Tools (brainstorms, flow diagrams, cause and effect diagrams, etc.)
  required
• Focus on continues improvement mindset, preferred
• Verbal and written English, required
• Strong to capture, describe and communicate ideas to the teamwork, preferred
• Auditor skills, preferred
• 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, Lotus Notes, etc. required
• Availability to work in different shifts, preferred.
• Molding process knowledge preferred
• High responsibility to finalize tasks
• Able to travel, if required
• English advance (B2)

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