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 through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our...

Position Summary: Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products.  Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.

Job Summary The Senior Incoming QC Lab Supervisor is responsible for overseeing all QC activities related to verification of requirements of incoming, in process, finished good materials, ensuring compliance with company procedures, work instructions and inspection plans and directing the QC staff as required to execute all required tasks. The Senior Incoming QC Lab Supervisor is also responsible for staff training and resource utilization. They should have advanced knowledge of mechanical inspections, processes, equipment, GD&T, and blueprint...

Position Summary: This position is responsible for providing daily administrative support to the Vice President, Worldwide Marketing & Service and overall department.  Plans and coordinated local and global team meetings and events.

Job Summary:   Directs the project team in a manner to achieve the business results expected. Works under the general direction of a Program Manager or Director of Programs. Plans and manages small to mid-size product development projects or plans and manages a major sub-project within a large multi-functional product development program. The position requires enthusiastic leadership skills in a highly technical medical instrument product development environment....

Job Summary   The Sr. Manager-Risk Management Process is responsible for managing risk processes throughout the product lifecycle, ensuring compliance with ISO 14971 standards, and collaborating with cross-functional teams. This role has responsibilities which include overseeing product quality, process reliability, new product development, validation, assisting with complaint investigations, non-conforming product resolutions, and corrective and preventive actions (CAPA) identifying and solving diverse problems to root cause, and implementing improvements that support business needs and goals. The Sr. Manager- Risk...

Job Summary   This position is responsible for the successful advanced connectivity of Werfen digital solution(s) and instrumentation for new and existing Werfen customers in collaboration with the Applications and IT Solutions implementation team. This includes, but is not limited to completion of all required post sale technical connectivity activities, ensuring the product application/solution functions to specifications. Ensures customer satisfaction during interface...

Position Summary:   This position is responsible for the successful implementation of Werfen’s data management solution(s) for new and existing Werfen customers in collaboration with the IT Solutions Architect.  This includes, but is not limited to, completion of all required post sale technical implementation activities, ensuring the product application/solution functions to specifications.  Ensures customer satisfaction during the installation, validation, integration and go-live processes.

We are looking for a Biologics Procurement Specialist manages the Reagent Donor Program including developing donor schedules to meet production schedule needs and communicating with donors and collection facilities to ensure blood collected is received in a timely manner. As a Biologics Procurement Specialist, is responsible for scheduling donors to meet Werfen's survey needs, managing donors samples sent for external testing and assist internal customers with red cell requests.   If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!  

Job Summary The Senior Systems Engineer plays a critical role in defining, developing, and integrating systems and software-level requirements for Werfen Autoimmunity’s in-vitro diagnostic (IVD) instruments in accordance with established Inova Diagnostics procedures (Design Control). The Systems Engineer establishes and performs testing (verification and validation) procedures and executes them for products under development and for design changes to existing products. Additionally, the Systems Engineer helps to trouble shoot issues with existing systems/instruments/software/reagents as part of the life cycle management under design...

Amazing Total Rewards for our Field Service 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 -

Amazing Total Rewards for our Field Service 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 -

Amazing Total Rewards for our Field Service 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 -

Position Summary:   Responsible for ensuring total customer satisfaction within the Werfen installed base.  Perform 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. 

Position Summary: Under general supervision, performs a variety of senior level technical and administrative duties in the production of complex assemblies and instruments involving electrical, mechanical and chemical processes. Participates in preparation and tracking of production and quality objectives, participates in data collection.

Position Summary Responsible for leading the process engineering and production support of a product or product line. Provides technical leadership and support for continuous improvement team efforts focused on process improvement and optimization. Provides engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization.

Job Summary   The Systems Engineer plays a critical role in defining, developing, and integrating systems and software-level requirements for Werfen Autoimmunity’s in-vitro diagnostic (IVD) instruments in accordance with established Inova Diagnostics procedures (Design Control). The Systems Engineer establishes and performs testing (verification and validation) procedures and executes them for products under development and for design changes to existing products. Additionally, the Systems Engineer helps to trouble shoot issues with existing systems/instruments/software/reagents as part of the life cycle management...

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: The Gulf South territory covers the following states: KY, TN, AR, AL and MS. Interested in candidates with a background in either sales or experience working as a Clinical Laboratory Scientist (CLS) or similar role in a hospital, research or reference lab.   This...

Job Summary   The Regulatory Affairs Director for Autoimmunity will build and lead a growing Regulatory Affairs team by recruiting, managing, coaching, and developing the team to ensure skills are aligned with a high performing organization. This position will direct the Regulatory team in supporting products (instrumentation, hardware, software, and reagents) over their lifecycle from new product development, market authorization documentation, labeling review, design changes, post market activities including field actions, reportable events, and...