Quality Assurance Manager

This position serves as site Quality representative for ConvaTec Slovakia, and is expected to ensure that Quality Management System are effectively executed to support business priorities, in line with Good manufacturing practices and other regulatory demands for medical devices production.
Ensure customer satisfaction and safety through the production and distribution of the highest quality products, with ongoing
• routine control of sterilization and final release of products,
• microbiological control of products and hygiene monitoring of production conditions,
• process & equipment validation and document control.

The plant produces mainly Catheters and Urine bags, employs close to 1000 people, and is currently investing heavily in new machines and a building expansion. The role will oversee around 40 employees in own function, with 6 direct reports and a sterilization facility as contractor.

Resource Management:

• Identify, hire, train and maintain qualified Quality Assurance personnel to support the Quality plans, objectives and goals.
• Assure adequate environment, facilities and equipment necessary for the Quality Assurance activities are implemented and maintained.
• Identify needs and perform training in the areas of Quality Assurance for personnel outside the Quality Assurance department.

System Management:
• To ensure that the Quality Management Systems is implemented and maintained in accordance with the regulatory requirements
• Oversee and coordinate the investigation of Customer Complaints, Nonconforming Product, Quality Management System Non conformances, Corrective and Preventive Actions activities. To coordinate the input for Medical Device Reports and the Post-Market Surveillance to ConvaTec RA in accordance with Quality Manual
• Plan, participate in, and oversee the completion of external audits at main suppliers / vendors
• Prepare a budget forecast for the costs and investments related to the Quality Assurance activities
• Assure establishing metrics for active monitoring of the product quality, identification of potential problems, areas where improvements and/or redefinition of quality acceptance criteria may be needed.

Management Representative:
• Assure that policies and processes required for an effective Quality Management System are established, maintained and communicated throughout the organization.
• Liaison and communication with external parties, including notified bodies, competent authorities and FDA as it is required, on matters relating to the Quality Management System.

Only the candidates who meet our requirements will be invited to the interview.
The selection procedure for the position will take place during the month of October – November 2015.