Rhian_Convatec | Site Quality Director

hace 4 semanas

reynosa, México Rhian_Convatec A tiempo completo

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

At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as our Site Quality Director and you’ll do the same.


This position is responsible for administrating the Local and Corporate Quality Management Systems and Strategies at the Infusion Care manufacturing site(s) in Reynosa Mexico, ensuring customer satisfaction and loyalty through the production and distribution of the highest quality products.

Your key responsibilities will include the following:

  • Responsible for the Quality Management organization at the ID Reynosa Unomedical/ConvaTec Group manufacturing site.
  • Recognized as an expert in operation quality systems and is sought out by others for guidance and advice.
  • Develops, communicates and executes plant Quality Management strategies and visions that are aligned to the Unomedical/ConvaTec Group business, Operations and Network objectives, corporate goals and Corporate Quality Management direction.
  • Continuously anticipates, assesses and manages current and future compliance and process risks with a focus on impact to business success.
  • Responsible for the development and management of the local plant Quality budgets meeting all annual budgetary targets.
  • In alignment with the global efforts, drives the implementation of local quality processes, strategies and resources in the manufacturing site of responsibility.
  • Proactively works with regional and local partners to ensure a constant state of quality system inspection readiness.
  • Creates and communicates an uncompromising commitment to quality and continuous improvement, maintaining a focus on meeting customer needs throughout the product life cycle.
  • Influences systems, processes and opportunities that encourage the leveraging of Quality resources across the Regional Quality Management network and the Corporate Quality Management network.
  • Works closely with regional Operations and sites, as appropriate, on the plant Leadership Teams.
  • Partners with Operations to execute and facilitate network initiatives in pursuit of business objectives and targets.
  • Works closely with the other Plant Quality Management Leads to ensure a harmonized approach to system, process and approach in execution of global strategy.
  • To comply with the company quality policy.
  • Ensure that the R&D and EPD projects, which are handled by the Product Quality Engineering group, are in compliance with QA and RA requirements.
  • Ensure that Quality Assurance System, which is handled by Quality Manager, is in compliance with entire ID.

The QA manager must cooperate and interact with the following in day to day activities/positions:

  • Management with Executive Responsibility
  • VP, Quality Assurance & Regulatory Affairs Director, Infusion care
  • All departments in BUD Mx and BU ID
  • Customers and Suppliers in relation to QA/RA areas, if required.
  • Relevant regulatory authorities, including the FDA, Competent Authorities and Notified Body, if required.

Comply with the safety, health and environmental policy and procedures established by EHS:

  • Be directly involved in corrective actions where they are related to other departments.
  • Maintain applicable documented information related to the EHSMS up to date.
  • Receive the necessary training to ensure adequate competence of their position and staff.
  • Prepare the necessary information to monitor, measure and analyse the different environmental objectives as applicable.
  • Understand EHS risks and all legal requirements related to their job responsibilities and the appropriate controls in place to manage those risks and requirements.
  • Perform their job responsibilities with due professional care and in compliance with legal requirements and internal standards without compromising their own safety or the safety of others.
  • Be aware of and support compliance with applicable significant environmental aspects and associated significant impacts.

Determine and establish corrective actions necessary for the optimal functioning of the environmental management system:

  • Authorize resources needed for the environmental management system and available.
  • Request the monitoring, measurement, analysis, and evaluation of the environmental performance of the organization at different levels as applicable.
  • Require, establish, implement, maintain, and continually improve an environmental management system.
  • Implement, maintain, review, and update the organization’s environmental policy and objectives.
  • Review the EMS to ensure continued suitability, adequacy and effectiveness and request adjustments accordingly.

We are looking for the following in our successful candidate:

Skills & Experience:

  • Strong experience in a QC/QA leadership role (manager), with at least 5 years in the medical device and/or pharmaceutical manufacturing focus.
  • Practical experience and global mastery in global quality standards and regulations governing medical products. Knowledge of CFR 820 regulation. Preferred, knowledge on MDR, Anvisa, JPAL, Canadian Regulation. Preferred, Regulatory compliance. Managed/supported front room during ISO 13485, MDSAP (preferred), FDA (Preferred) Audits.
  • Ability to think in clear, decisive manner, remaining calm under challenging conditions.
  • Ability to efficiently work through quality, organization and business issues with a focus on solutions and proactive contingency planning in support of the customer and business objectives.
  • Ability to apply budgetary analysis principles and effective allocation of internal/external resources.
  • Understanding of risk management principles and ability to apply these principles in day to day Quality Management activities, quality and compliance issues and business challenges.

Qualifications/Education:

  • Minimum of B.S., or equivalent, in a scientific/technical discipline is required. Advanced degree (M.S., M.B.A., Ph.D. or equivalent) preferred.
  • 13485 Auditor (Certified) preferred.
  • Certifications in Quality Management Systems (ex. ISO 9001 Lead auditor, ASQ Certified Quality Manager, etc.) preferred.
  • Six Sigma Green Belt Certified (Black Belt preferred).
  • Speaking: Fluent Spanish – English professional level.
  • Writing/Reading: Fluent Spanish - English professional level.

This role will include around 5% travel.

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