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Position part of the procurement team focused in improving and re-evaluating the procurement activities, optimizing the organization's supply base and increasing its overall value proposition. Focused on the total cost of ownership, this position also considers product quality, customer needs, organizational goals and market conditions as an essential part of the procurement process. Actions are driven by a rigorous and collaborative approach, based on fact analysis and market intelligence, following the Strategic Sourcing Framework. Ensure the availability of raw material, both; short and long term, through regular monitorization of critical raw materials and a continuous analysis of risks to define risk mitigation actions. Regular reporting and analysis of the main purchasing KPIs, such as • Obsolescence Main responsible for the price negotiation and the management of materials savings initiatives in line with profit plan and overall business objectives. Negotiation of supply agreements as needed to support the critical business needs: • Monitorization and renewal of existing Supply and Quality Agreements, • Ensures Supply and Quality Agreements are positioned appropriately before business is initiated with new vendors Improve the value-to-price relationship with suppliers following Strategic Sourcing Framework • Quarterly communication of raw material forecast, • Follow up calls with all the vendors, • Annual visit plan with key vendors, • Attendance to main exhibitions Supports Supplier Quality department to accomplish the goals defined in supplier quality system • Annual risk analysis of raw materials and definition of key vendors list, • Analysis of vendors performance Ensure the maximum quality of the purchased products • Follow up of technical problems with Supplier Quality, Technical Support, R&Dor Manufacturing departments Contribute to keep updated the material and supplier database Strategic activities • Development and implementation of the Strategic Sourcing strategy, • Develop key performance measures for chosen suppliers and negotiate on multiple variables to award longer-term strategic contracts that result in significant cost reduction and improved service levels, • Monitor current category market conditions, technology roadmaps and identify supply/demand challenges & opportunities., • Identification of new suppliers in collaboration with R&D during the development of new products, • Identification of potential risk and definition of mitigation action plans, • Involvement in the total cost analysis for new product developments To be determined based on department needs, to include interactions such as: • Supplier Quality: Control change notification management and vendor's complaints support, • Manufacturing: Support in solving technical issues related to raw material or packaging performance, • R&D: Support in the development of new products and identifying suppliers for new assays, • Supply Chain Department; Including warehouse and planning, • Sales and Marketing: Benchmarking of vendors, • Quality Control The ideal candidate for this position will exhibit the following skills and competencies: • Management of decisions under pressure., • Methodical and well-organized person., • Teamwork, • 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, • Good reporting and analysis capabilities, • Reflects values of Werfen in the quality of work and working relationship. Education: • Required: Bachelor's degree (Diplomatura) in the biological or related sciences. Degree may be substituted by relevant skills and work experience, • Valuable: Any additional degree higher than the required Experience: • Professional experience is required, minimum of 5 years in a similar position, • Software: Fluency in Office Tools (Excel & Word), Valuable advanced knowledge in SAP, • Language: Fluency in Spanish or Catalan. Advanced knowledge of English (reading, writing and speaking) Additional Skills/Knowledge: • Software: Fluency in Office Tools (Excel & Word), Valuable Advanced knowledge in SAP, • Language: Fluency in Spanish or Catalan. Medium knowledge of English reading, writing and speaking) #J-18808-Ljbffr

Please note that while the internal job title for this position is 'Regulatory Affairs Lead', this is an individual contributor role that does not involve team management or project leadership This position provides effective regulatory support for company's manufactured products and customer's products. Prepare and submit the documentation according to the corresponding legislation for the different countries. Be responsible for the implementation of new regulatory requirements. • Prepare the required documentation to obtain the CE mark, FDA, or other country registrations for the company's manufactured products or customer's products in accordance with current legislation. Communication and maintenance of products with Spanish authorities., • Support customers with any regulatory aspect., • Follow up and resolve requirements that emerge during registration procedures., • Maintain technical files as necessary to sustain product approval., • Review product materials, labeling, and/or specification sheets for compliance with applicable regulations and customer policies., • Be part of CFT projects as the RA representative., • Support internal and external audits, validations, and product risk analysis., • Follow management indicators/metrics for the proper performance of the department and apply appropriate corrective actions if necessary., • Support the Market Surveillance Department in compiling information for Post-Market Surveillance., • Recommend and manage, if applicable, changes to company procedures/documents (quality system and compliance) to comply with current regulations, guidelines, and/or standards., • Provide support to Customer Service regarding product import/export., • Ensure effective partnering and collaboration with R&D, Quality Operations, Design Quality, and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions., • Ensure all documentation is RA-reviewed before it is shared externally with regulators and/or customers., • Collaborate with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspections. To be determined based on department needs, to include interactions such as: • All departments of the company., • Customers., • Regulatory agencies., • Required: Bachelor's degree (diplomatura) in Life Sciences, Engineering, or Physical Science. Degree may be substituted by relevant skills and work experience., • Valuable: Any additional degree higher than required., • Required: 3 years in a similar position., • Software: Fluency in Office Tools (Excel & Word); basic knowledge of SAP is valuable., • Languages: Fluency in Spanish or Catalan; advanced knowledge of English (reading and speaking)., • Standards: Knowledge of IVD legislation and the healthcare sector is valuable., • Management of decisions under pressure., • Methodical and well-organized approach., • Teamwork., • Ability to express information clearly and concisely to staff, ensuring understanding., • Ability to apply a systematic approach with constant control, follow-up, and verification of results., • Analytical thinking and problem-solving., • Ability to collaborate, participate, and coordinate actively with working groups., • Reflects Werfen values in work quality and working relationships. #J-18808-Ljbffr

Werfen seeks a QS Engineer to maintain the core QMS, manage audits, and drive continual improvement across the organization. You will act as an SME for QS processes and support CAPA and change control activities. The role requires a bachelor’s in a science field, several years in quality, and fluency in English with Spanish or Catalan skills. SAP knowledge and regulatory awareness are valued in this on-site Barcelona area position. #J-18808-Ljbffr

Biokit seeks a Quality Assurance / Regulatory Affairs professional to oversee design control and ensure regulatory compliance for new and existing assays. The role emphasizes risk management, change control, and continuous improvement of quality systems, requiring fluency in Spanish or Catalan and s

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. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. The Maintenance Manager is responsible for ensuring the safe, reliable and compliant operation of industrial maintenance and hard facility services in a regulated manufacturing environment. The role oversees corrective and preventive maintenance, calibration activities, utilities, infrastructure, technical documentation, contractor performance and budget control. It requires strong technical knowledge, leadership capability, cross-functional collaboration and a continuous focus on safety, compliance, service quality and business continuity. Industrial Maintenance: Including corrective maintenance, preventive maintenance and calibration management, ensuring equipment reliability, compliance and operational continuity. Hard Facility Services: Including utilities, infrastructure and building-related technical services, through a fully outsourced model, ensuring effective contractor performance and alignment with site needs. Budget Control: Define, monitor and control the maintenance expenditures and investments, optimizing financial, technical and human resources according to business priorities. Technical Documentation Management: Manage technical and legal documentation, technical drawings and electrical schematics related to facilities, utilities and equipment, ensuring accuracy, availability, version control and readiness for audits, inspections and maintenance activities. Operations and Manufacturing: Alignment of maintenance priorities and production continuity. Engineering, Automation and Projects: Coordination of installations, upgrades and infrastructure improvements. Quality, Regulatory Affairs and Compliance: Support for documentation, deviations, audits and GMP/ISO requirements. EHS, Security and Facility Management: Oversight of safety, permits and infrastructure risks. R&D, Laboratories and Technical Services: Support for laboratory, cleanroom and equipment requirements. Suppliers, Service Providers and Subcontractors: Planning, supervision and performance monitoring. People Function and Leadership: Coordination of workforce planning, team development and performance management. Education: Bachelor's degree in Engineering, Industrial Engineering, Maintenance, Facilities Management or a related technical field. Additional training in facilities, utilities, project management, safety or regulated environments is valued. Experience: At least 5 years in maintenance, hard facilities, utilities or engineering management, preferably in regulated manufacturing, diagnostics, medical devices, pharmaceutical, biotechnology or laboratory environments. People Management: Experience leading technical teams, setting priorities and developing team capabilities. Technical Knowledge: Knowledge of preventive and corrective maintenance, HVAC, cleanrooms, purified water, electrical, pneumatic, mechanical, instrumentation and laboratory facility systems. Project and Contractor Management: Experience managing renovations, installations, commissioning support, subcontracted work, budgets and technical documentation. Systems and Tools: Proficiency in Microsoft Office and maintenance management systems; SAP knowledge required or strongly preferred. Languages: Fluency in Spanish or Catalan, with advanced English for technical documentation and communication. Compliance: Knowledge of safety requirements, audit readiness and GMP/ISO 13485-oriented practices. Sound decision‑making under pressure, balancing safety, compliance, cost and business continuity. Structured and disciplined approach to planning, execution and follow‑up. Ability to lead technical teams, develop capabilities and foster accountability and collaboration. Clear and effective communication with users, managers, suppliers and cross‑functional stakeholders. Strong prioritization and time management in demanding environments. Analytical approach to root cause analysis, risk assessment and sustainable improvement. Service‑oriented mindset focused on internal customer needs. Effective collaboration with multidisciplinary teams and external partners. Strong commitment to safety, compliance, documentation discipline and Werfen values. Occasional travel may be required, typically less than 5% of working time. #J-18808-Ljbffr

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. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong. The Quality Systems (QS) Engineer is responsible for maintaining the core Quality Management System (QMS) processes, including Document Control, Change Control, Internal Audit and Training Management, and ensure the company is compliant with all applicable regulations and standards. The QS Engineer operates with a high degree of autonomy in the planning, coordination and execution of audits, and, upon qualification through the internal auditor qualification program, is authorized to conduct internal audits independently. The role serves also as a subject matter experts (SME) for the QS processes, providing technical guidance and support across the organization. In addition, the QS Engineer actively contributes to the continual improvement of the QRA function and supports the effective management of Non-conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement initiatives. • Organize and coordinate internal and external audits, including planning, execution and follow-up activities., • Conduct internal audits upon successful completion of the Internal Auditor Qualification Program., • Lead backroom activities during external audits and host the frontroom activities during internal audits., • Develop the annual Quality Training Program based on identified organization needs, support its deployment, and monitor its effective execution., • Collect, analyse and communicate training feedback to trainers to support the continous improvement of training content and delivery method., • Oversee the preparation, implementation and completion of Annual Training Plans., • Design and develop training materials, and provide guidance and support to other departments in training-related activities., • Deliver Quality and GMP-related training sessions across the organization., • Maintain the Documentation Management System., • Manage documents of external origin. Participate in the impact assessments, action plan definition and follow up of the changes needed., • Coordinate Management Review activities and maintain the associated documentation., • Prepare general internal communications within the Quality and Regulatory Affaris (QRA) area., • Maintain the Change Management System, ensuring effective coordination, tracking and timely implementation of changes and associated actions., • Perform quality assessment of change requests, as required., • Monitor, analyse and report the Key Performance Indicators (KPIs) related to QS-owned processes., • Own Non Conformities, Change Controls and CAPA directly involving QS-owned processes., • Manage Non Conformities, Change Controls and CAPA related to cross-functional Quality Management System processes., • Monitor the progress and timely closure of audit-related Non conformances and associated CAPA., • Participate in the design, implementation and continuous improvement of core Quality System processes., • Prepare and maintain Quality Management System documentation required to support international registrations, in accordance with the registration timelines., • Respond to customer quality questionnaries., • Manage projects autonomously and actively contribute to the continual improvement of the department., • Serve as a subject matter expert (SME) of QS-owned processes during audits and inspections, and providing guidance and support across the organization. This position involves frequent interaction with all areas of the company and includes delivering training to employees across different functions. • Required: Bachelor’s degree (Grado) in Chemistry, Biotechnology or other Sciences, complete with competency in chemical, biological, or health-related work experience., • Degree may be substituted by relevant skills and work experience., • Valuable: Any additional academic qualification beyond those required in the previous section, including a Master’s degree in Quality Management., • Minimum of 3 years in a similar position., • Software: Good knowledge of Microsoft Office and Adobe applications. Basic SAP knowledge is desirable, together with a proven ability to adapt to new technologies. Experience in digitalizing and optimizing processes will be considered an asset., • Language: fluent in Spanish and/or Catalan, with advanced English communication skills (both written and spoken)., • Standards: Extensive knowledge of regulatory requirements applicable to medical devices and/or in vitro diagnostic medical devices, as well as Quality Management Systems. Knowledge of additional regulations and standards will be considered an asset. Management reserves the right to substitute relevant professional experience for academic qualifications and/or to make exceptions to the required years of experience., • Management of decisions under pressure., • Methodical and well-organized person., • Ability to apply a systematic approach and constant control, follow-up and verification of the results., • Time-management skills., • Teamwork., • Ability to collaborate, participate and coordinate actively with working groups., • Excellent communication skills, with the ability to present information clearly and concisely while ensuring audience understanding., • Reflects values of Werfen in the quality of work and working relationships. Not required. #J-18808-Ljbffr

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 and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. The Systems Engineer supports R&D instruments through installation, maintenance, diagnostics, troubleshooting, modifications, and upgrades. The role links assay development and instrumentation by translating laboratory, user, and scientific needs into system-level requirements and capabilities. It applies scientific judgment to laboratory work, data analysis, deviation investigation, and interpretation of experimental and system performance. The position manages workflow, documentation, reporting, interfaces, and incident communication using company processes and systems. Working with R&D, Instrumentation, Engineering, Quality, Operations, and Technical Support, the role helps ensure instrument availability, reliable testing, and clear communication of risks, deviations, progress, and recommendations. Key Accountabilities • Act as a technical bridge between scientific development and instrumentation development, ensuring assay, laboratory, instrument, and system requirements are understood, aligned, and clearly communicated., • Perform and support laboratory procedures, experiments, system tests, and troubleshooting activities requiring scientific judgment and technical understanding., • Select appropriate experimental, analytical, and technical methods; contribute to protocols; and support interpretation of experimental and system performance data., • Detect deviations in results, system behavior, or instrument performance; identify potential causes; and recommend modifications to protocols, workflows, methods, or technical approaches., • Support internal instruments through diagnostics, troubleshooting, preventive maintenance, repair coordination, modifications, upgrades, and technical follow-up., • Compile, analyze, and interpret experimental and technical data; perform calculations; and prepare graphs, summaries, and reports to communicate findings, problems, and progress., • Provide project updates and communicate technical status, results, risks, deviations, and recommendations to supervisors, senior research staff, and cross-functional stakeholders., • Write or contribute to laboratory procedures, technical summaries, reports, reviews, protocols, and documentation under appropriate supervision and approval when required., • Ensure electronic and paper records, technical data, and work documentation are accurate and compliant with applicable guidelines, procedures, and good documentation practices., • Manage workflow, technical reporting, incident communication, autonomous task execution, escalation of risks or issues, and compliance with company processes, quality expectations, and the Ethics Code. Internal Networking This role interacts with multiple internal functions to ensure effective communication between scientific, technical, quality, and operational perspectives. To be determined based on department needs but, typical interactions may include: • R&D colleagues, including scientists, technical scientists, and development teams., • System Development and Engineering groups, including CSW and IL, involved in instrument, hardware, software, or system-level activities., • Quality Control, Quality Assurance, and Operations colleagues to support regulated development, documentation, technical investigations, and workflow alignment., • Technical Support and service-related teams to exchange information on instrument performance, issues, diagnostics, repair needs, and field-relevant feedback., • Manufacturing, logistics, and other technical departments. Minimum Knowledge & Experience required for the position • Required: Bachelor’s degree or equivalent technical qualifications in electrical/mechanical engineering or physical sciences., • Valuable: Any additional degree higher than what is required in the previous point. Any additional degree, specialization, or advanced training higher than the minimum requirement, particularly in systems engineering, biomedical engineering, instrumentation, diagnostics, laboratory sciences, or related technical/scientific areas., • Years of experience, • Experience is not required., • Valuable: Professional experience in in vitro diagnostic development, technical service, instrumentation, systems integration, or high-end life sciences/medical equipment, particularly in roles involving laboratory procedures, assay development, instrument troubleshooting, data analysis, and cross-functional technical communication. Additional Skills/knowledge: • Data analysis skills, including the ability to manage data sets, perform calculations, interpret results, and prepare graphs or technical summaries using scripting programming languages like Python or R., • Knowledge of basic software tools such as Excel, Word, and PowerPoint; knowledge of SAP is preferred., • Laboratory experience, including basic knowledge of biological and chemical laboratory procedures and the ability to operate laboratory equipment., • Working knowledge and ability to test, troubleshoot, and support electrical, mechanical, digital, or instrument-related areas., • Ability to understand and connect assay behavior, laboratory workflows, instrument performance, and system-level interactions., • Familiarity with design control processes and quality standards as required for the role. Language: • Fluency in Spanish or Catalan., • Advanced knowledge of English (reading, speaking and writing). Skills & Capabilities: • Strong attention to detail and accuracy., • Excellent analytical and troubleshooting skills, with the ability to investigate deviations, identify possible causes, and recommend corrective or improvement actions., • Ability to apply scientific methods, theoretical knowledge, and technical reasoning to tasks within one or more areas of expertise., • Ability to work in a multidisciplinary environment involving science, electronics, mechanics, software, pneumatics, fluidics, quality, and operations., • Strong teamwork and interpersonal skills, with flexibility to support multiple people, projects, and technical needs., • Clear oral and written communication skills, including the ability to explain technical or scientific issues to different audiences., • Excellent organizational, time management, and multi-tasking skills., • Ability to work independently on assigned activities with moderate guidance and to upscale risks or issues appropriately., • Curiosity, willingness to learn, and adaptability in a flexible and changing R&D environment., • Proactive, organized, resolute, and able to communicate results, problems, and progress within the group and across departments when required., • Reflects the values of Werfen and OEM in the quality of work and working relationships. Travel Requirements Sporadic travel or short-term assignment to an external may be required (up to 10% of the time). Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V. #J-18808-Ljbffr

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