Manufacturing Specialist
hace 1 semana
Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products. Collaborate in maintaining the quality system documentation processes and procedures adopted by the company. Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence. Coordinate and support the preparation of software technical documents appropriate for regulatory submissions. Support the regulatory submissions for market authorization for medical device products. Facilitate the approval process for software releases. Disseminating knowledge about the Quality System and regulatory requirements. Oversee post‑market surveillance activities related to medical device products. Networking/Key relationships A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector Knowledge and experience working with medical device international regulations and related standards (ISO , ISO ,..).Knowledge and experience working in Medical device software life cycle process (IEC ) Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA..) Good level of Technical and Conversional English.
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Senior Field Specialist
hace 18 horas
Lliça d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Within a...
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Senior QARA Specialist
hace 18 horas
Lliça d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Purchasing Specialist
hace 49 minutos
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Customer Services Specialist
hace 5 días
lliçà d'amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Customer Services Specialist
hace 49 minutos
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Customer Services Specialist
hace 4 días
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Senior QARA Specialist
hace 3 días
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Senior QARA Specialist
hace 7 días
Lliçà d'Amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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R&D Scientist I
hace 19 horas
lliçà d'amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
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Senior QA Leader
hace 19 horas
lliçà d'amunt, España Werfenlife SA. A tiempo completoWerfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays...
