The Laboratory Services Superisor performs a variety of tasks and functions associated with the appropriate day-to-day operations of the Quality Laboratories and supervises the performance of a variety of tasks within the division.   Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. Serve as main point of contact for Laboratory Services. This includes but is not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, serological duties, chemistries and any other task associated with making sure the products reach the...

Job Summary  

The Software Technical Support Representative level 3 role is vital in ensuring the reliability, performance, and compliance of software used in clinical diagnostics and patient care. This position actively supports software and hardware systems across North America, specifically focusing on the software suites for the Transplant business. Expertise in IT support, networking, software implementation, server management (both Linux and Windows) is required, alongside customer-facing technical support experience in a regulated medical device environment.

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 QC Technologist I is responsible for the execution of a broad range of bench test procedures used in the testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory.  The QC Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards.   

Job Summary   Under direction of North America Marketing, this role will plan, schedule and execute digital campaigns and programs. This position requires enthusiastic leadership, coordination, and collaboration skills. This individual is required to lead multi-functional marketing and sales staff to develop high value digital marketing programs. The individual will develop the annual design and calendar of digital marketing initiatives, including campaign development,...

Position Summary: Under direction of the department manager, provides technical assistance to customers and Werfen field personnel within a product line responsibility.  Troubleshoots, over the phone, answers a broad range of technical questions regarding instrument performance, instrument capabilities, QC concerns and other product concerns as required.  Assists in the training and direction of new personnel within the department.

Position Summary: Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) 217/46, as well as other country regulatory agencies.  Represents regulatory on design teams, prepares regulatory plans, authors US FDA 510(k)s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion.  Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.

The Director, Regulatory Affairs is responsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on global regulatory submission strategy, regulatory submissions, adverse event reporting / field actions, and interaction with global regulatory authorities related to Werfen Transfusion portfolio. The Director, Regulatory Affairs provides direct regulatory support for multiple Transfusion projects within the Transfusion Technology Center.

  Job Summary Patient Blood Management (PBM) Specialists are responsible for Rotem and VerifyNow instrument and P&E revenue growth within their assigned geography.  To grow revenue, PBM Specialists will present health economic and clinical information, IT solutions, and instrument demonstrations to hospital departments associated with transfusion and Patient Blood Management including the cardiac operating room, transplant, trauma, blood bank, laboratory, and purchasing.  Additionally, PBM specialists will build physician...

Position Summary: The Calibration and Plant Services Coordinator is responsible for administering the SAP Plant Tool System for tracking Calibration and Maintenance records for all equipment within the plant. The Calibration and Plant Services Coordinator is also responsible for maintaining the spare parts catalog, scheduling with service vendors and procurement of machine and facilities related parts.

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 -

The Transfusion Global Marketing Product Manager will be responsbile for collaborating closely with cross functional teams to identify market needs to support new product development projects to assist in growing the Transfusion revenue globally. This position will also manage global implementation of new product development projects while working closely with the Global Commercial Marketing organization. This position will also be responsbile for ongoing lifecycle management activities to support buiness continuity, including, but not limited to supporting post market survillance acitivities.

Job Summary   The Director of Sales, Business Unit is responsible for national sales, budgeting, and expenses management within Werfen's North American Commercial Operations for their assigned Business Unit. In this high-level leadership position, the Business Unit Director will influence, develop, and implement long-term strategies and key performance indicators. This role requires high levels of collaboration with internal customers as...

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

Job Summary   The position is responsible to ensure that the Design Control and Risk Management activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our SaMD, SiMD and Digital products. This position provides project-level leadership, develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development,

Position Summary The position is responsible to ensure that activities throughout the product lifecycle are compliant with procedures, standards, and regulations applicable to our products. The position works independently and with guidance from manager 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. This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement,...

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 International Customer Service Coordinator I is responsible for processing all customer orders in the system with a high level of accuracy.This role involves issuing credit and debit requests, entering system tickets for discrepancies and interacting with the sales team as needed. The primary focus of this role is ensuring precise and timely order entry.