The Director, Quality Assurance will manage quality projects, lead Continuous Improvement initiatives, and will drive change to further integrate and implement Ivenix Infusion System into the Fresenius Kabi organization and systems. A key aspect will be to ensure compliance with the U.S. regulatory requirements and FDA expectations are met. This will be in close cooperati

The Controlled Substance Specialist is responsible for providing independent oversight and guidance for Distribution Center processes to ensure compliance to DEA and FDA regulatory requirements for the handling, processing, and reconciliation of controlled substance and List 1 chemical products. Provides direct non narcotic support to area manager when not involved in mon

Responsible for Electrical Engineering tasks within a sustaining engineering role function, specifically in a manufacturing environment. Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generates and implements i

This Position is responsible for the calibration, routine inspection, testing, maintenance and repair of instruments, meters, gauges and other testing and measuring equipment. The goal of a Calibration Specialist is to ensure the accuracy and precision of the measurements taken using this equipment. Responsibilities 1) Responsible for maintaining, monitoring and routinely

Responsible for the accurate weighing, checking and mixing of specific chemical compounds for product formulations; the calibrating and monitoring of a variety of mixing machinery and the accurate documenting and maintaining of production logbooks and records. They're also required to follow all departmental and company SOP's and maintain accurate and timely record keepin

Perform standard computer science and software validation tasks of creating automated manufacturing tests used in the assembly and testing of medical devices in a manufacturing environment. Select appropriate techniques to solve problems and make design recommendations under direction of supervisor. Assess results for application, validity and conformance to specification

This Position is responsible for the calibration, routine inspection, testing, maintenance and repair of instruments, meters, gauges and other testing and measuring equipment. The goal of a Calibration Specialist is to ensure the accuracy and precision of the measurements taken using this equipment. Responsibilities 1) Responsible for maintaining, monitoring and routinely

Job function requires strict adherence to safety requirements, SOPs, cGMPs, Batch Records and other controlling documentation. Inability to comply with safe work could result in serious injury to self others or serious damage to equipment or destruction of product. Job function requires joint work efforts with others and ensuring group safety practices are met. Job functi

The Manufacturing Technician II is responsible for effectively troubleshooting the cause of manufacturing non conformances of in process medical devices and making the required repair in accordance with manufacturing procedures. The position includes performing testing, sorting, and rework of non conforming parts found in manufacturing or at receiving inspection. Other re

The Manufacturing Engineer responsibilities include using technical expertise in support of daily operations in packaging operations by defining, measuring, analyzing, coordinating, implementing and follow up concerning projects and activities designed to increase or improve safety, quality, productivity, and/or capacity. Apply accepted engineering practices and project m

Perform standard Mechanical Engineering tasks within a sustaining Engineering role function, specifically in a manufacturing environment. Select appropriate techniques to solve problems and make design recommendations under direction of Supervisor. Assess results for application, validity, and conformance to specifications. Utilize engineering tools to solve technical pro

Perform standard Mechanical Engineering tasks within a sustaining Engineering role function, specifically in a manufacturing environment. Select appropriate techniques to solve problems and make design recommendations under direction of Supervisor. Assess results for application, validity, and conformance to specifications. Utilize engineering tools to solve technical pro

POSITION SUMMARY Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas. Responsibilities

The Engineering Specialist (Hardware) will perform mechanical engineering, technical project management and provide guidance/leadership responsibilities in the hardware development team. Lead activities by driving, planning, directing and implementing designs and improvements to the mechanical systems in Fresenius Kabi infusion devices to achieve product performance goals

We hire you at an Entry Level and you advance by demonstrating growing skill levels of operating and maintaining production equipment. Within one year, you will be able to fully operate state of the art equipment through advanced HMI interfaces. For those individuals with Team Leader/Supervisor experience, we offer opportunities to become a technical expert and lead our o