Quality Assurance Specialist for Medical Devices
hace 4 días
At Medtronic, a leading healthcare company, you can embark on a rewarding career of innovation and exploration while championing healthcare access and equity worldwide. With our Global Quality Strategy rooted in the Medtronic Mission and Quality Policy, we strive to be trusted partners who prioritize patient safety, uphold product quality, and maintain high ethical standards in our business relationships and programs.
About the RoleWe are seeking an Audit Specialist (Internally and externally) based remotely in Spain to support Compliance, Quality Management System (QMS) projects, and Change Control activities as outlined in relevant Internal Quality agreements. As part of our 'Put Patients First' initiative and the Global Regions Audit program, you will serve as an Auditor or Lead Auditor, playing a crucial role in ensuring compliance and excellence.
Key Responsibilities:- Follow up, manage, and provide guidance on audit program, audit observations, and child Project Records (PRs) performance actions.
- Provide training to individuals engaged in internal and external audit processes across Global Regions, including TrackWise system utilization.
- Support and document KPIs related to monthly audit, change control, and QMS objectives, with mitigation, correction, and improvement plans in case of unaccomplished targets.
- Collaborate closely with operating groups and Compliant Quality System (CQS) team to provide guidance, expertise, and monitoring of audit, change control, and QMS processes.
- Bachelor's degree in Life Science, Engineering, or a related field (e.g., Pharmacy, Biomedical Engineering).
- At least 3 years of experience in a Quality role within the Healthcare industry, with a focus on ISO 13485, ISO 19011, and/or GxP requirements (Good Practice), such as Good Distribution Practice (GDP) and Good Manufacturing Practices (GMP).
- Fluency in English and Spanish (both verbal and written).
- Project management skills.
- Able to work virtually with all parts of the region.
Estimated Salary: €50,000 - €70,000 per annum. This compensation range is based on industry standards and takes into account the candidate's level of experience, qualifications, and location in Spain.
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