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QUALITY ASSURANCE MANAGER

Descripción de la oferta de empleo

Join a visionary team at the forefront of biosensor technology, revolutionizing clinical diagnostics. Our client, a trailblazing deep tech organization, is on a mission to enhance and accelerate diagnostic services in healthcare settings. With roots in an illustrious academic institution, they blend years of research in photonics, chemistry, and clinical science, targeting critical gaps in the healthcare industry. This opportunity is more than a job; it's a calling for those who are driven to make a real difference in health and wellbeing.OPPORTUNITIESEngage full-time with a company that's a leader in nurturing talent.Thrive in an environment that prizes accountability and is actively shaping a more diverse, equitable, and inclusive future.Experience swift career progression in a diverse team of engineers and scientists.Impact society positively from the start of the project.Work closely with empathetic pioneers in photonics, chemistry, and medicine.WE'RE SEEKINGA committed QA Manager to guide the creation and implementation of a QMS that meets international criteria, with the backing and insight of a regulatory affairs consultancy. This role is critical in assuring that our products are developed and produced to the highest standards, and you'll be central to our strategy for achieving market approval globally.KEY ROLESEstablishing and enforcing a robust QMS in line with ISO 13485 and 9001 for IVD products.Steering the product approval process, ensuring cross-departmental collaboration.Building lasting relationships with external QA/RA entities, including regulators and inspectors.Developing policies that reflect our commitment to unmatched quality.Launching SOPs and conducting thorough internal audits to assure process integrity.Fostering a workplace ethos of quality and excellence.Working with executives to pinpoint crucial QA/RA success metrics.QUALIFICATIONSBachelor's degree in engineering, life sciences, or a related healthcare field.A track record of successfully deploying ISO 9001-compliant QMS.Understanding of key standards such as ISO 13485, ISO 14971, IEC 61010, IEC 62304.Exceptional communication, precision, initiative, and leadership.Fluent in English, with strong writing and speaking skills.PREFERABLYMinimum 3 years in QA/RA within the medical device industry.History of involvement in the authorization of IVD devices.Thorough knowledge of relevant ISO standards and EU IVD Regulation (EU) 2017/746, along with US-FDA regulations.Prior experience in a medical technology start-up or SME.Certified Quality Auditor (CQA) status.
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Detalles de la oferta

Empresa
  • Steneg & Partners
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 21/04/2024
Fecha de expiración
  • 20/07/2024
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