Esta oferta de trabajo no está disponible en tu país.
Quality & Regulatory Manager
SGSmurcia, EspañaHace 21 días
Descripción del trabajoOwn and oversee all medical devices processes, including the Quality Manual, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, quality management reviews, concessions, and impartiality. Supervise the implementation and maintenance of the medical quality management system (QMS), ensuring alignment with global processes and accreditation requirements. Ensure impartiality and independence from commercial interests, including conducting annual risk analyses. Maintain QMS regulatory compliance to support designation and accreditation under MDR / IVDR, ISO 13485, MDSAP, and other relevant schemes. Lead internal and external audits and ensure timely closure of CAPAs. Conduct the annual Quality Management Review and ensure timely follow-up and closure of actions. Write and revise QA-related procedures and associated documentation. Continuously optimise the QMS to improve turnaround times while maintaining compliance. Make decisions related to the Notified Body QMS and proactively drive continuous improvement initiatives. Compile and analyse data for management review reporting. Manage all regulatory processes to ensure full compliance across all Medical Schemes. Ensure all contractual agreements, including those with inter-office and subcontractors, are current, compliant, and properly maintained. Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices. Planand implement relevant regulatory training programs in collaboration with training team . Ensure the SGS Medical website remains current and accurate in terms of regulatory content. Build strong working relationships with global medical device teams and proactively work on projects with stakeholders Provide technical support and training across the business, when required Manage and develop the Quality & regulatory team, including performance management, coaching, and staff development. Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP Strong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level Ability to represent SGS to medical device regulatory authorities and other external fora Excellent interpersonal and communication skills including fluency in English Negotiation and persuasion skills Change Management skills Strong organisational skills and flexibilty 5+ years’ experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a Notified Body organization (a must have). 2+ year experience in team management (must have) Has at least 10 years’ experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories or Industry Has a keen eye for detail and is focussed on delivering results within agreed timeframes Operates ethically with the highest degree of professional integrity Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject. Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485 Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry. Flexible schedule and hybrid model. SGS university and Campus for continuos learning options. Multinational environment where you will work with colleagues from multiple continents. Benefits platform.
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include : Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
Job Description
Main Purpose of Role
- To centrally manage a Lean and compliant Quality Management system for medical devices schemes (Medical includes Notified Body NB1639, UKCA, ISO 13485, MDSAP and all other Medical Schemes at SGS)
- Management of external audits and communication with competent authority
- Management of internal audits and communication with relevant departments
- Maintaining designation under MDR / IVDR and support the development and designation under new schemes
- Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes
- Coordinate all activities with auditing organisations ( Belgian and English competent authority, UKAS, ….)
- Coordinate all complaints and regulatory request (CEF) to provide customers and CA appropriate answers
This role will report to the Head of Certification and Compliance, Business Assurance.
It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.
Key Accountabilities
Skills & Knowledge
Essential
Qualifications
Essential
Please send your CV in English
Additional Information
Why SGS?
Join Us : At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.
Crear una alerta de empleo para esta búsqueda
Quality Manager • murcia, España
Ofertas relacionadas
)
- Oferta promocionada
Senior Electrical Engineering - CARTAGENA
Technip Energiescartagena, España We are currently seeking an Electrical Senior Engineer to join our team based in Cartagena, Murcia.A Specialist Electrical Engineer with experience in QHSE (Quality, Health, Safety, and Environment...Mostrar másÚltima actualización: hace 4 días
- Oferta promocionada
Manager
Unidata (Universal Data SL)Región de Murcia, Spain El puesto consiste en apoyar a la dirección de la empresa con el objetivo de impulsar el negocio y acompañar en la toma de decisiones estratégicas.
Se comienza como apoyo directo a dirección, pero e...Mostrar másÚltima actualización: hace 2 días
- Oferta promocionada
Area Sales Manager - Calzado / Marroquinería
Elastron GroupElche, Valencian Community, Spain Multinacional, distinguida por la Bolsa de Valores de Londres como empresa inspiradora, pretende incorporar a su equipo un / a Comercial (H / M / D).
Prospección en el mercado nacional y captación de nuev...Mostrar másÚltima actualización: hace 16 días
- Oferta promocionada
Senior Process Engineers Cartagena
Tecnicas ReunidasCartagena, Región de Murcia, Spain Técnicas Reunidas group (TR) is a leading Oil & Gas International Engineering and Construction Company specialized in the design, construction and management of execution of Industrial plants world...Mostrar másÚltima actualización: hace 23 días
- Oferta promocionada
Responsable de Calidad
ATRIO FOODSOrihuela, Valencia, SPAIN Unete a ATRIO FOODS si te interesa crecer y disfrutar de la creciente actividad del sector agroalimentario!.ATRIO FOODS, es un joven grupo agroalimentario con fabricas de conservas y V gama que est...Mostrar másÚltima actualización: hace 23 días
- Oferta promocionada
Quality Assurance Specialist (pharma)
Randstad EspañaRegión de Murcia, Spain Reconocida compañía de la industria farmacéutica, precisa incorporar un / a Quality Assurance Specialist para su planta ubicada en la provincia de Murcia.
Mantenimiento del sistema general de calidad,...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
QUALITY ASSURANCE TECHNICIAN
Linneo HealthFuente-Álamo de Murcia, Región de Murcia, Spain Buscamos un / a QUALITY ASSURANCE TECHNICIAN para nuestras instalaciones ubicadas en Balsapintada, Murcia.Como empresa joven e innovadora, dinámica, y con grandes expectativas de crecimiento en un me...Mostrar másÚltima actualización: hace 14 días
- Oferta promocionada
International Area Manager
Bioarray Genetic Diagnosiselche, España Bioarray Genetic Diagnosis is a genetic testing provider that serves clinical partners across Europe, Latin America, MENA, and Asia.
Using arrays such as CGH and NGS, Bioarray offers services in Med...Mostrar másÚltima actualización: hace 14 días
- Oferta promocionada
Controller RRHH
Koala BayElche, Valencian Community, España Koala Bay es una marca de moda española que nació en el año 2011.Estamos presentes en el canal Wholesale, online y en el canal Retail con más de 54 tiendas propias en las costas más soleadas del Me...Mostrar másÚltima actualización: hace 3 días
- Oferta promocionada
Compliance lead (Quality)
HeroAlcantarilla, Región de Murcia, España We are a multinational food company that conserves the goodness of nature in our products.We carefully select our fruit and vegetables from their origin, maintaining the highest quality and safety ...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Quality & Regulatory Manager
SGSmurcia, murcia, España We are SGS – the world's leading testing, inspection and certification company.We are recognized as the global benchmark for sustainability, quality and integrity.
Our 99,600 employees operate a net...Mostrar másÚltima actualización: hace 21 días
- Oferta promocionada
Beca en Departamento de Calidad - Perfil Ingeniería Materiales / Química
HaysAlhama de Murcia, Región de Murcia, Spain Desde Hays nos encontramos en búsqueda de un / a.Estarás en contacto con todas las áreas de la compañía, dentro de un entorno multinacional, con un equipo multidisciplinar y con equipos pioneros.Te i...Mostrar másÚltima actualización: hace 14 días
- Oferta promocionada
Senior Electrical Engineering
Technip EnergiesCartagena, Región de Murcia, Spain We are currently seeking an Electrical Senior Engineer to join our team based in Cartagena, Murcia.A Specialist Electrical Engineer with experience in QHSE (Quality, Health, Safety, and Environment...Mostrar másÚltima actualización: hace 5 días
- Oferta promocionada
Quality Assurance Lead
Nuitéemurcia, España QA Lead – Nuitée (Barcelona, Dublin, London or Casablanca or Remote EU).API infrastructure of the global travel industry.
OTAs, fintechs, banks, and super-apps to access hotel inventory in real time...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Integration Expert
HeroAlcantarilla, Murcia, SPAIN We are a multinational food company that conserves the goodness of nature in our products.We carefully select our fruit and vegetables from their origin, maintaining the highest quality and safety ...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Key Account Manager | Comercial –Soluciones de Digitalización Industrial (Murcia y alrededores)
Konetic Digital FactoryAlhama de Murcia, Murcia, SPAIN Quieres formar parte de una empresa tecnológica que impulsa la transformación digital de la industria?.En Konetic Digital Factory estamos en plena fase de expansión y buscamos un / a Comercial con vi...Mostrar másÚltima actualización: hace 20 días
- Oferta promocionada
Técnico / a de gestión de calidad - Sector Naval
ALTENCartagena, Región de Murcia, España Únete al equipo Alten y comparte tu experiencia como Técnico / a de Calidad!.En ALTEN tenemos claro que el éxito de nuestros proyectos se debe a las personas que forman nuestro equipo.Por eso, si tie...Mostrar másÚltima actualización: hace 3 días
- Oferta promocionada
Transformation Office Manager
HeroAlcantarilla, Región de Murcia, Spain We are a multinational food company that conserves the goodness of nature in our products.We carefully select our fruit and vegetables from their origin, maintaining the highest quality and safety ...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Global Process Expert
Heroalcantarilla, España We are a multinational food company that conserves the goodness of nature in our products.We carefully select our fruit and vegetables from their origin, maintaining the highest quality and safety ...Mostrar másÚltima actualización: hace más de 30 días
- Oferta promocionada
Manager Finanzas (SAP FI / CO / TR)
STRATESYSAlhama de Murcia, Murcia, SPAIN Con la próxima apertura en la Región de Murcia de nuestro nuevo Centro de Excelencia SAP, buscamos incorporar a un / a Especialista S / 4HANA Finance.
En esta posición tendrás un rol estratégico y de al...Mostrar másÚltima actualización: hace 4 días