Quality Systems Specialist - Syx-44

Detalles de la oferta

.At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. Our America's Shared Services Center (SSC) is looking for an Audit Specialist (Internally and externally) based remotely in Spain.In this exciting opportunity, you will support Compliance, Quality Management System (QMS) projects, and Change Control activities as outlined in relevant Internal Quality agreements. Additionally, you may assist in further QMS activities under the 'Put Patients First' initiative and the Global Regions Audit program, serving as an Auditor or Lead Auditor.Responsibilities may include the following and other duties may be assigned:Follow up, manage, and provide guidance to audit program, audit observations, and child Project Records (PRs) performance actions.Provide training to all individuals engaged in the internal and external audit processes across Global Regions, including the use of the TrackWise system.Support and document KPIs related to the monthly audit, change control and Quality Management System (QMS) objectives, and provide mitigation, correction, and improvements plans in case of unaccomplished with the KPIs targets.Collaborate closely and directly with the operating groups and the Compliant Quality System (CQS) team to provide guidance, expertise, and monitoring of all activities within the Audit, Change Control, and QMS processes.Provide expertise and guidance in interpreting policies, regulations, and procedures to ensure compliance, and participate in projects within the audit, change control and QMS processes.When acting as the owner of documents or processes, ensure that all related activities are updated and aligned with the applicable QMS requirements.Fulfil any additional responsibilities defined in the Service agreements between the Center-Led team and other entities at the Global Regions level.Required Knowledge and Experience:Bachelor's degree in Life Science, Engineering, or a related degree (e.G., Pharmacy, Biomedical Engineering).At least 3 years of experience in a Quality role within the Healthcare industry, with a high focus on ISO 13485, ISO 19011, and/or GxP (Good Practice) requirements, such as Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP).Fluent in English and Spanish (both verbal and written).Project management Skills.Ability to work virtually with all parts of the region


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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