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- , United States of America

Director, Quality Role Purpose: The Site Quality Leader is responsible for all Quality activities at the Puerto Rico facility. The incumbent will serve as Management Representative for the Quality System and lead the following functions: Quality Systems, Quality Engineering, Regulatory Compliance, Laboratory Operations, Product Release, Complaints Investigations, Internal Audits, Receiving Inspection and Supplier Quality. This position reports directly to the VP of Quality for the business....


Process Safety Engineer Bachelor's Degree in Engineering, Occupational Safety or related discipline and at least three years of related experience required. The ideal candidate will have a minimum of seven years of related experience. Main Objective: The Process Safety Engineer supports the safe operation of complex manufacturing systems through the identification of potential risks, evaluation of existing practices, and assisting in the development and implementation of controls to ensure a....

- Any US State

Engineer Electrical Main Objective: Responsible for support and development of Class I and II medical devices, which includes, production support, service support, troubleshooting, design transfer support, training, prototyping, design assurance testing, development support from prototype through production release. Essential Duties and Responsibilities:Design of electronics/firmware using modeling, simulation, and analysisElectronic/Firmware/Software design in support of senior design....


Sterilization Sciences Specialist Essential Duties and Responsibilities:Participate in design review meetings and as a key member of product design teams to assess and validate devices for proper sterilization methods, e.g., radiation, ethylene oxide, etc.;Generate assessments and/or validations for new device introduction or process/product changes for impact to sterilization and end-user cleaning using microbiological and sterilization theories and practices according to applicable ISO....


Sterilization Operations Supervisor Main Objective: Reporting to the Operations Manager, the Sterilization Operations Supervisor ensures maximum utilization of equipment and oversees or performs the scheduling and processing of product and quality requirements for multiple shifts. Supervises Sterilization Technicians and Material Handlers, providing inputs to Engineering and Maintenance. Ensures that all operations meet or exceed regulatory and Company standards. Essential Duties and....


Sterilization Engineer Main Objective: Maintain Manufacturing sterilization process in accordance with Quality Systems Requirements. Essential Duties and Responsibilities:Become proficient in the use and diagnostics of ethylene oxide sterilization equipmentManage and maintain Manufacturing ethylene oxide sterilization cyclesManage and maintain sterilization compliance with appropriate regulatory standardsPerform sterilization cycle evaluations and validations in conjunction with the....


Main Objective: The Manager, Quality Systems and Regulatory Compliance is responsible for managing, improving and maintaining the global Quality Management System (QMS) to ensure compliance to FDA QSR, ISO 13485, and all other applicable regulatory requirements. Essential Duties and Responsibilities:Ensure that the global QMS is maintained to comply with the most current applicable FDA, ISO and other international regulations. Provide training to relevant personnel as required.Lead, manage and


Engineer-Mechanical Automation Main Objective: To design and develop the mechanical aspects of automation equipment used in the Final Device Assembly and Packaging department. Act as an engineering resource for all activities required to implement the designed or purchased equipment into manufacturing. Essential Duties and Responsibilities:Complete mechanical design of automation equipment and/or tooling capable of assembling and/or packaging medical devices in a clean room environment.Support


Product Development Engineer As Product Development Engineer you will be a critical player in turning concepts into exciting new health care products. This person will be depended on the Product Development Engineer as a solid modeling expert to develop, recommend improvements to, revise and analyze solid models and device assemblies. The Product Development Engineer will also support prototyping, evaluation of prototypes and testing of new assemblies. Your knowledge and skills in....


Cost Accounting Manager Main Objective: This position is responsible for analyzing and communicating information and proposing methodologies to company management to help optimize the companies costs of goods sold, and to ensure the proper valuation of accounting standard costs, inventories and fixed assets for purchased and manufactured products worldwide. ESSENTIAL DUTIES AND RESPONSIBILITIES:Ensure timely and accurate monthly financial close with adequate controls and reviews in....


Quality Engineer Main Objective: Responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. Essential Duties and Responsibilities:Responsible for participating in design and development projects and assuring the design process meets all requirementsResponsible for reviewing design drawings for tolerance, inspect-ability and quality....


Manager - QMS Technical Training Main Objective: Designs, deploys and evaluates learning and development programs and services supporting the company QMS competency demonstration training needs under the supervision of the HR Director in liaison with the Quality Director. Essential Duties and Responsibilities:Analyzes needs, develops and administers budget and staffing recommendations, establishes learning objectives, designs, develops, markets and deploys training programs and other learning....


Supervisor - Sterilization Operations Main Objective: Reporting to the Operations Manager, the Sterilization Operations Supervisor ensures maximum utilization of equipment and oversees or performs the scheduling and processing of product and quality requirements for multiple shifts. Supervises Sterilization Technicians and Material Handlers, providing inputs to Engineering and Maintenance. Ensures that all operations meet or exceed regulatory and Company standards. Essential Duties and....


Sr Engineer Industrial Main Objective: Increase the productivity of manufacturing and business related processes while reducing waste by analyzing product specifications, and then use mathematical models to design systems and methods that will help the business meet production goals. Essential Duties and Responsibilities:Responsible to accurately develop/manage capacity models and analysis results for all shop floor and critical upstream supply activitiesIntegrate individual models with other....


QA Validation Engineer Main Objective: Responsible for supporting the Validation Manager with all process validation related support for the life cycle development and manufacturing of Class I, II and III medical devices. Essential Duties and Responsibilities:Responsible for writing of protocols and conducting validations of special processes, including cleaning and passivation, electropolishing, molding, etc.Responsible for reviewing and approving validations of special processes performed at


Sr - Manufacturing Engineer Swiss Machining Main Objective: Design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise to create, document and implement required procedures and documents. Essential Duties and Responsibilities:Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers, Quality Engineers and....


Supervisor - Suture/Textile Manufacturing Main Objective: To oversee, manage and provide direction to the manufacturing department that will effectively and profitably meet or exceed the internal and /or external client’s expectations by providing superior quality products and service. Essential Duties and Responsibilities:Perform training of manufacturing teams, test comprehension and evaluate training effectivenessMonitors production plan meeting daily production schedules and reports....


Sr Manufacturing Engineer CNC Milling Main Objective: Design, develop, implement and improve manufacturing processes to produce cost effective quality medical device products and systems. Provide manufacturing engineering expertise in our CNC MIlling area to create, document and implement required procedures and documents. Essential Duties and Responsibilities:Work with project teams to identify issues and risks. During new product development integrate with Engineers, Design Engineers,....


Sr Manufacturing Engineer - Tool & Fixture Design/Automation Main Objective: As part of the Continuous Improvement Team, provide Engineering Support and Guidance for the – Tool & Fixture design/Automation . Analyze, design, implement and improve manufacturing processes through creative effective use of fixturing and mechatronics to produce cost effective quality medical device products and processes. Provide fixturing and mechanization/ automation engineering expertise to create,....


Engineering Program Manager - I&R Main Objective: The Engineering Program Manager is primarily responsible for leadership and coordination of multi-system, multi-subsidiary, or highly complex engineering projects within the global engineering team. This includes adhering to policies and procedures necessary to ensure efficient and effective execution of a portfolio of programs, progress reporting, and assistance in resolution of obstacles and challenges. ESSENTIAL DUTIES AND....

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