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Position Summary:
Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support...
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Job Summary
Responsible for overseeing the day-to day activities of the complaint team, works to assure timely case/complaint review and assignment. Responsible for managing the escalation process of potentially reportable complaints with attention to country specific reporting timeliness The QA Manager works with cross functional teams to support complaint escalations, investigations and field actions.
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Job Summary
The Temporary 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...
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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.
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Position Summary:
This position is responsible for ensuring that pre‑market and/or post‑market regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in...
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Position Summary:
The Senior Software Quality Engineer position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. In this capacity the Sr SWQE independently develops, applies and implements methods, tools and practices while working with project teams to achieve product quality goals and requirements in the areas of design, development, cybersecurity, verification and validation, maintenance and service. This is a technically focused role requiring advanced...
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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...
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Job Summary:
Plan and manage small to mid-size product development projects across multiple phases within a large multi-functional product development program; or plan and manage multiple small, related projects which together constitute a program. The position requires, enthusiastic leadership skills in a highly technical medical instrument product development...
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Job Summary:
The Sr. Facilities Technician Electrical / HVAC will perform duties and tasks in the operations, maintenance and repair of building equipment, systems and infrastructure. Primary responsibility for trouble shooting, operation and maintenance of building Electrical/HVAC equipment including, lighting installation and repairs, bus duct (Starline) tap can installations, wiring of production equipment and systems, operation of fire alarm system, package HVAC units, refrigeration equipment, air compressors, air handlers and building environmental...
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Job Summary
The Director of Service Operations is a key leadership role responsible for designing, implementing, and governing the operational backbone of the service organization. This position ensures that service processes, systems, and standards are harmonized across all service areas to deliver consistent, efficient, and compliant support for customers and internal stakeholders.
The scope of responsibility includes oversight of inventory and logistics, calibrated tools administration, and governance frameworks...
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Position Summary:
Fully competent in one or more scientific/technical areas. Plans and conducts scientific assignments requiring mastery of specialized techniques.
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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.
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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...
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Position Summary:
This position is responsible for the successful implementation of advanced Werfen digital solution(s) for new and existing Werfen customers in collaboration with the Applications implementation team. 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 installation, validation, integration and go-live processes.
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Position Summary:
Responsible for technical user support and security in the company's local area networks. Maintains hardware and software on the company's network servers and user workstations. Monitors and controls data communications equipment and software
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Position Summary:
Under minimal supervision, as a member of the R&D Software Engineering team at Werfen, this role focuses on both offensive and defensive cybersecurity, as well as operational security. The primary responsibilities include identifying and validating vulnerabilities, mitigating risks, and ensuring compliance with regulatory standards to safeguard critical systems in highly regulated industries using software engineering tools and techniques available.
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Position Summary:
Under general supervision, this position supports the production of medical devices. Duties include a variety of technical support and administrative duties related to complex electro-mechanical test equipment and hand fixtures. Duties are performed within a cGMP/regulated environment with proper documentation of work performed.
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Job Summary
Manage a portfolio of programs and projects that support a business line. The portfolio will contain both large multi-functional programs a set of hardware, software, and sustaining projects that support the business line. Provide direct supervision to program and project managers who have a responsibility for a program\project within a portfolio. Participate in the strategic planning process needed to implement the business...
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Job Summary
- The Global Support Engineer, Reagents (GSE Reagents) is the subject matter expert for all Werfen Transfusion reagents used for manual, Capture, and all automated instrumentation.
- The GSE Reagents will provide technical expertise as it pertains to reagents to the Transfusion Technical and Service teams, including the Product Investigation (PI) Lab when needed.
- This expertise can be provided to internal commercial and technical teams through training.
- The GSE Reagents will be the liaison between the service and technical...