Quality Engineering Engineer

hace 1 día

Lliçà d'Amunt, España Werfen A tiempo completo

Overview The mission of this position is to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Werfen immunoassay sells the products. Assure that all products manufactured at Werfen Immunoassay are designed, manufactured and released according to established procedures. In addition this role works with specific manufacturing teams to drive continuous improvement of Quality within manufacturing – seeking defect rate reduction, increased manufacturing efficiency, reduced costs and enhanced customer satisfaction. Responsibilities Key Accountabilities Review and approval of manufacturing and general procedures. Development of Quality Improvement plan for manufacturing area of responsibility. Measurement and reporting of Quality KPIs and metrics for manufacturing area of responsibility. Change Management: evaluate the impact of the proposed changes and management of change control. Validation: Be able to establish a strategy to validate changes. Review and approve validation strategies and the corresponding documentation (protocol and report). Risk Assessment: perform, review and approve the risk assessment performed at Biokit to evaluate the impact of changes and non-conformances in the final product. Participate in Internal and External Audits. Perform Quality Training to all personnel at Immunoassay. Management of Non-Conformities and CAPA's. Review of product Batch Record as needed. Internal Networking The main interactions are with: Operations and Quality Control. Qualifications Minimum Knowledge & Experience required for the position Degree/studies Required: Bachelor's degree (Diplomatura) in Chemistry, Biotechnology or other Sciences. Degree may be substituted by relevant skills and work experience. Valuable: Any additional degree higher than the required. Years of experience Required: 3 years in a similar position. Min knowledge Software: Fluency in Office Tools (Excel & Word), Valuable Basic knowledge in SAP. Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading and speaking). Standards: Knowledge of Quality standards. Skills & Capabilities Management of decisions under pressure. Methodical and well-organized person. Teamwork. Time management skills. Ability to express information clearly and concisely to the staff, ensuring their understanding. Ability to apply a systematic approach and constant control, follow-up and verification of the results. Ability to collaborate, participate and coordinate actively with working groups. Reflects values of Werfen in the quality of work and working relationship. Travel Requirements Not Required  What we offer A meaningful project that will impact the quality of laboratory medicine worldwide Multicultural and friendly team Exciting opportunities for professional development. Ongoing training Social benefits: Canteen, nursery check, training, private medical insurance, retirement plan If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV. Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer

  • Quality Engineering Engineer

    hace 23 horas

    Lliçà d'Amunt, España Werfen A tiempo completo

    OverviewThe mission of this position is to guarantee that the Standards under which the Quality System is based are aligned with the requirements of the different Regulations of the Countries and Organizations where Werfen immunoassay sells the products. Assure that all products manufactured at Werfen Immunoassay are designed, manufactured and released...

  • Engineer, R&D Software Engineering

    hace 1 semana

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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.The Senior...

  • Quality Engineering Lead

    hace 23 horas

    Lliçà d'Amunt, España Werfen A tiempo completo

    A leading life sciences company in Lliçà d'Amunt, Spain, seeks a Quality Assurance Specialist. This role ensures that the Quality System aligns with regulations while driving improvements within manufacturing. Candidates must have a Bachelor's degree in Chemistry, Biotechnology or similar, along with 3 years of relevant experience. Responsibilities include...

  • Senior Software Development Engineer

    hace 4 semanas

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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...

  • Senior Software Development Engineer

    hace 6 días

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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...

  • Senior Software Development Engineer

    hace 1 semana

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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...

  • Senior Software Engineer

    hace 1 semana

    Lliçà d'Amunt, España Werfen A tiempo completo

    A global leader in specialized diagnostics is seeking a Senior Software Development Engineer in Lliçà d'Amunt, Spain. In this role, you will engage in all facets of software development, focusing on C++. Responsibilities include leading projects, ensuring code quality, and collaborating with team members in an agile environment. This position offers a...

  • Senior Software Development Engineer

    hace 1 semana

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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...

  • Product Technology Engineer

    hace 2 semanas

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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. This...

  • Senior Software Development Engineer

    hace 4 semanas

    Lliçà d'Amunt, España Werfen A tiempo completo

    Werfen 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...