Werfen   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...

Position Summary:   Responsible for ensuring total customer satisfaction within the Werfen installed base.  Preform installations, validations/verification and training on Werfen analyzers.  Provide on-going clinical support, customer education and consult with customers regarding matters of regulatory requirements and compliance. 

Job Summary Responsible for the strategic planning for the assay development and product development teams to align with corporate objectives. This position will lead the discovery, design, development, and optimization of diagnostic products and assays for our IVD product portfolio. This role will oversee teams to drive innovation in transfusion diagnostics to meet clinical needs and regulatory requirements.

Position Summary:   Defines and implements market requirements for new products. Product management of a dedicated product line. Prepares marketing support program for a specific product, product line, or product area. Coordinates implementation with technical services and field sales organization. Provides Marketing assistance to field personnel and customers.

Job Summary   The Principal Systems Integration Engineer proactively leads and contributes to multiple moderate to complex projects and design changes in support of development and investigations.  Responsible for developmental activities as well as design verification and validation related to products, assays, software and hardware.

Job Summary The Program Manager of the Project Management Office (PMO) will be responsible for leading, scaling, and optimizing programs within North America Commercial Operations. This role will define and drive programs using program management strategies, ensuring alignment with organizational priorities and industry best practices in a highly regulated environment. As a key member of the organization, the Program Manager will contribute to the governance, execution, and continuous improvement of project management standards while serving as a cross-functional business partner in business transformation initiatives. This role will drive...

Position Summary: Performs basic filling and packaging functions, and formulations as required, in support of Coagulation, Clinical Chemistry and Critical Care product lines; uses automated and manual methods in accordance with established Quality standards and cGMP's

Position Summary: Under minimal supervision, leads software development activities including software requirements, architecture, design, implementation, and integration.

Job Summary The Document Control Specialist III guides, executes, and improves Document Control processes including document changes, quality records control, labeling creation, SAP master data entry, and training record maintenance activities. This role ensures compliance with organizational standards and regulatory requirements and improves the efficiency and quality of Document Control processes. The Document Control Specialist III demonstrates subject matter expertise in document control processes and regulatory requirements. The position is responsible for carrying out activities and facilitating processing associated with change orders, SAP...

Position Summary:   Using Engineering procedures standard for research and development, carries out assignments associated with research, design, development, support or manufacturing of specific parts, processes, software or components of medical diagnostic systems.  Independently evaluates, selects, and applies standard engineering techniques, procedures, and criteria, using judgment in making minor adaptations and modifications.  Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more...

Position Summary: Performs basic filling and packaging functions, and formulations as required, in support of Coagulation, Clinical Chemistry and Critical Care product lines; uses automated and manual methods in accordance with established Quality standards and cGMP's

Job Summary   The Paralegal is responsible for supporting the commercial, clinical, and corporate activities of the Transfusion and Transplant business lines of Werfen. Responsibilities include but are not limited to contract review, assistance with registrations and filings, litigation management, negotiation, and analysis in alignment with corporate strategy and goals. The role will report to the Assistant General Counsel and will collaborate closely with other key internal business partners, external parties, and other members of the Legal department. ...

Position Summary: The position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products.  This position provides project/program level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service.  Provides mentoring and consultation to QE staff on relevant issues.

Job Summary:   Plan and manage a large multi-functional product development project and/or several small multifunctional product development projects simultaneously.  The projects may include large multi-functional projects or a combination of hardware, software, and sustaining projects.  The position requires strong, enthusiastic leadership skills in a highly technical medical instrument product development...

Position Summary: Performs analyses of Clinical Chemistry, Co-Oximeter, Coagulation and/or Microbiology controls and reagents using various automated and manual techniques in accordance with established Quality and GMP requirements.

Position Summary: This position will focus on SAP and mainly on the QM module. Candidate will analyze the business needs of users and designs information systems and applications suited to their needs.  Programs (ABAP Programming), tests and implements programs, and trains system users under supervision of the IT Development Manager, IT Development Director, or IT Senior Director.

Job Summary   The Clinical Scientific Manager (CSM) fulfills two key functions within the Strategic Business Unit (SBU) for Autoimmunity in San Diego. The CSM plays are key role as Autoimmunity’s scientific subject matter expert by representing the company at a worldwide level and assisting in identifying, developing and maintaining relationships with international key medical experts and opinion leaders, as well as support of scientific studies. This position plays a crucial role in promoting scientific understanding of our assays and developing content to promote their value to our customers. In addition, the CSM...

Amazing Total Rewards for our Sales Team! - Generous Base Salary + Incentive Compensation - Company Vehicle with Personal Use Allowance - Phone & Internet Reimbursement - 8% 401k Match (dollar for dollar!) - Comprehensive Health Care Benefits - Company...

Job Summary Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area. Responsible for managing and leading the work of direct and...

Position Summary: Performs inspection and monitoring of all incoming materials that require inspection, including but not limited to packaging, chemicals, subassemblies, mechanical and electrical components.  They are inspected in accordance with FDA/GMP requirements and established company SOPs and specifications.