Project Quality Engineer

Rhian_Convatec; Reynosa; Presencial; MXN 916,000 - 1,283,000; Jornada completa

Descripción de la vacante

A global medical solutions company in Reynosa, Mexico is seeking a Project Quality Engineer to ensure compliance with quality standards, manage investigations, and drive continuous improvement. The ideal candidate has a Bachelor's degree in engineering and at least 3 years of experience in quality management. Proficiency in English at C1 level is required. This role promises development opportunities in a dynamic environment.

Formación

• Six years of experience in Engineering areas required.
• Strong experience with Quality Management Tools necessary.
• Training on ISO 13485 and FDA QSRs preferred.

Responsabilidades

• Assure the process control during product manufacturing.
• Support the quality system by addressing non-conformity activities.
• Coordinate and lead investigations related to quality issues.

Conocimientos

Verbal and written English, C1 level

Experience in Cost Reduction projects

Focus on continuous improvement mindset

Educación

Bachelor’s degree (Mechanical, Electronic, Industrial or similar)

Herramientas

MS Office

Descripción del empleo

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. We hold leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide 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). For more information, visit www.convatecgroup.com.

About the role

The Project Quality Engineer will support production as a main leader, ensuring compliance with regulations, standards, QMS internal procedures on new projects, process improvements, validation and 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 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 product quality standards.
• Support the quality system by focusing on adequate handling of non‑conformity activities, corrective and preventive actions.
• Define a classification of all Non‑Conformities based upon risk.
• Coordinate and lead investigation/root cause analysis with the team members involved (maintenance, production, logistics, engineering, etc.).
• Review, update and develop procedures, instructions, quality specifications as needed.
• Collect and review objective evidence to complete investigations and thereby achieve correct NC closure and assure effectiveness of established actions.
• Follow up the QA roll as per NC procedure required (for instance, Originator, Owner, Quality Reviewer, Approver, etc.).
• Monitor process KPIs (PPMs, NCs, etc.) and present any trending to the NCRB, taking actions if needed.
• Ensure actions are supported or referenced to the quality system.
• Promote ideas for continuous improvement of quality with the aim of achieving system simplicity.
• Support areas where experience and technical knowledge about problems can be useful (production, microbiology, systems, etc.).
• Perform internal process audits when required.
• Maintain communication with other departments (MX / DK) regarding any quality problem.
• Create quality alerts and provide support on defining quality criteria when needed.

Projects & Validation related

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

Safety, Health, and Environment Responsibilities

• Comply with safety, health and environmental policy and procedures established by the EHSMS.
• Maintain applicable documented information related to the EHSMS up to date.
• Participate in committees, trainings, and awareness activities to ensure proper competency of the position.
• 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 necessary actions to achieve intended results.

Requirements

• Verbal and written English, C1 level minimum (MUST).
• CQE (Certified Quality Engineer by ASQ) preferred.
• Experience in Cost Reduction projects preferred.
• Black Belt certification preferred.
• Bachelor’s degree (Mechanical, Electronic, Industrial or similar education).
• Minimum 3 years’ experience in Engineering areas.
• Strong experience handling QMS (Quality Management System).
• Strong experience with Quality Control Charts (histogram, Pareto, process capability calculations, control charts, etc.).
• Strong experience with Quality Management Tools (brainstorming, flow diagrams, cause and effect diagrams, etc.).
• Focus on continuous improvement mindset.
• Training/Knowledge on FDA QSRs and GMPs, ISO 13485, J‑PAL/Ordinance No. 169, EU and Canadian medical devices regulation, or similar regulations preferred.
• Familiar with common computer software packages (MS Office, etc.) required.
• Availability to work in different shifts.
• Molding process knowledge.
• Ability to travel if required.

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [e-mail].

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.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third‑party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and view "Convatec Internal Career Site - Find Jobs". Thank you.