Overview:
Ensuring that appropriate Quality systems are established, implemented, and maintained in each market in scope, and appropriate oversight is in place to ensure that local regulatory requirements can be supported in a simple, compliance and continuous improvement manner.
Responsibilities:
Keep the documentation of the manual, processes and procedures of the Quality Management System updated.
Collect input information on the performance of the Quality Management System to organize the annual management review meeting.
Participate in the meetings for the design and implementation of the Quality Management System and subsequent follow-up meetings.
Deploy the objectives and improvements of the Quality Management System that are approved in the annual review of the system by the Management.
Inform Management about behavior and opportunities for improvement.
Support Quality training program to all staff to the knowledge of applicable regulatory requirements and Quality Management System requirements.
Record quality incidents and undertake their treatment.
Internal and External Audit Plan.
Providing support to Quality teams in the resolution of serious quality issues and quality management documentation.
Third Party quality management oversight: Manage technical quality agreements with Third Partiers, establish a good quality management oversight in routine operations, identify risks and propose risk mitigation.
Collect, prioritize, drive and monitor execution of strategic Quality initiatives.
Develop and carry out rigorous monitoring of the indicators (quality metrics) of the established processes and inform the Management of any deviation in the fulfillment of its goals.
Support in the implementation of Quality digitalization strategy.
Before a product is released, its conformity is properly checked by the quality management system used in its manufacture.
Stay current with the applicable regulations and promote Quality across the organization. Assure compliance of UNE-EN ISO 13485 standard, GxP, regulatory and internal standards according to quality policies and applicable requirements within affiliates/subsidiaries. Management of quality documentation (procedures, reports, etc.). Management of quality technical agreements and their fulfilment. Support to affiliates/subsidiaries.
Directly supervise the activities of manufacture, import, grouping, and/or sterilization of medical devices.
Verify that the products manufactured, imported, grouped, sterilised or reprocessed comply with the requirements of the applicable regulations.
Supervise the documentary archive of products that are manufactured, grouped, sterilized, imported and/or reprocessed and that are marketed or put into service.
Review and evaluate incidents related to the products they manufacture, group, sterilize and/or import for the surveillance system and have the means to communicate them to the health authorities.
Supervision of the registration of implant cards in implants that require it.
Be an interlocutor with the health authorities and collaborate with them in the execution of the appropriate measures, such as the withdrawal of the product from the market.
Interlocutor with the external consulting entity and the certification body.
Provide the health authorities, whenever required, with the documentation that guarantees the conformity of the products with the provisions of the legislation.
Preparation and supervision of communications for the marketing or commissioning of class IIa, IIb and III devices, and in vitro diagnostic medical devices class B, C and D or included in Annex II and devices for self-testing.
Preparation and supervision of the documentation required for the registration of those responsible for placing medical devices on the market.
Preparation of the application for health authorization and direct supervision of clinical research.
Supervision of messages aimed at advertising and promotion of products.
To identify, evaluate the risks to which medical devices are subjected.
Qualifications:
Education: University Degree in Pharmacy. Pharmaceutical Industry Master will be a plus.
Languages: Fluent in English. Spanish will be a plus.
Experience (years/area): A minimum of 3-5 years' experience in similar positions. Essential minimum 2 years' experience in quality assurance or quality systems in production plants, distribution center and/or affiliates.
Specific Knowledge: European and international level. cGMPs, cGDPs, Quality for Marketing Affiliate. Quality Assurance and Quality control and/or manufacturing processes. Office system.
Experience in UNE-EN ISO 13485 standard, applicable regulations in the field of medical devices will be considered.
Travels: Willing to travel occasionally.
Personal skills: Good communication skills, proactivity, energy, good working under pressure, problems-solving, good organizational skills and persistent.
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