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Sr. Quality and Regulatory Compliance Engineer Responsibilities:Assures Regulatory and Quality compliance in the area of verification and validation, design controls, and design transfer engineering for biomaterial products.Contributes to and executes engineering schedules and plans.Supports new product launches in compliance with EMA, FDA, and Notified Body requirementsReviews and approves written reports and engineering documentation as necessary.Executes tactical implementation of strategic


Manager - Sales & Operations Planning Main Objective: This role will manage all aspects of strategic, long-range planning decision making; working cross-functionally with supply, demand, sales and finance teams. Essential Duties and Responsibilities:Serve as the main point of contact regarding all S&OP mattersLead S&OP process through collaboration with Sales, Product Management, Finance, and OperationsEnsure organizational alignment between all functions related to....


QA-Engineer-Assembly/Packaging This position requires a Bachelor's Degree and at least three years of experience in QA/QC, preferably in medical device manufacturing. ASQ CQE certification, ISO 13485 auditing experience, Lean/6σ experience and clean room experience with assembly/packaging would all be highly desired. 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....


Warehouse Manager Main Objective: The Warehouse Manager will be responsible for managing all internal warehouse operations to meet daily customer requirements. Essential Duties and Responsibilities:Manages, coaches, mentors, motivates and trains warehouse employeesMonitors SAP Warehouse Activity to ensure teams meet internal and external customer requirementsMonitors overall warehouse performanceIdentifies, coordinates, assigns and implements warehouse projects as necessary to meet corporate....


Quality Systems and Regulatory Compliance Engineer Main Objective: Responsible for supporting the Quality Systems and Regulatory Compliance (QSRC) Manager with all quality related support for improving and maintaining the global Quality Management System (QMS) to ensure compliance with FDA QSR, ISO 13485, and all other applicable regulatory requirements. Essential Duties and Responsibilities:Responsible for participating in QSRC projects and assuring the QMS meets all requirements.Responsible....


Manager - Quality Engineering-Design Quality Engineering Manager We are looking for a dynamic and inspiring Quality Engineering Manager to join and support our growing corporate Design Quality team. We are looking for an experienced manager to continue our development and enhancement of efficient, best in class, systems supporting new product development and design controls. You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer,....


Quality Engineering Manager Main Objective: To oversee, manage and provide direction to the Quality 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:Manages and directs the efforts of the Quality Control Inspectors and Quality Control Supervisors.Supervises Quality Engineers and Quality Assurance Technicians assigned to manufacturing....


Sr Design Assurance Engineer-Electrical 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,....


Director of Quality Main Objective: Responsible for ensuring that the Manufacturing Quality System is effectively established, deployed, maintained, and continually improved. Works closely with the Director of Operations and the Global Director of QA to drive and maintain world class manufacturing operations and quality outcomes. Develops and mentors QA leaders and staff. Monitors and reports on the performance of the quality system to management and establishes the format and frequency of....


Engineering Project Manager MAIN OBJECTIVE: Responsible for full life cycle development of Class I and II medical devices, which includes initiation, design, development, execution, verification/validation, release, and product maintenance. ESSENTIAL DUTIES AND RESPONSIBILITIES: Using lean techniques and tools, manage the complete life cycle of critical projects from concept through production release and post-market surveillance. Lead cross-functional, matrixed teams to complete project....


Sterilization Sciences Specialist We are looking for a strong, self-motivated Sterilization Specialist to join and support our growing corporate team. We are looking for an experienced professional to continue our development and enhancement of efficient, best in class, systems supporting new product development for sterilization and end-user cleaning. You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to supporting....


Sr. Supplier Quality Assurance Engineer Main Objective: To manage and maintain supplier base to assure products and processes internally and externally meet specifications, improve supplier product quality performance, and determine adequate receiving inspection plan. Essential Duties and Responsibilities:Responsible for reviewing design drawings and processes with suppliers to assure inspectability and compliance.Work with suppliers to improve product and process quality through onsite....


Manager - Product Surveillance Main Objective: Ensure compliance in the areas of complaints, consisting of but not limited to; FDA Med Watch filing, CMDCAS Adverse Event filing, MDD Vigilance Reporting. Essential Duties and Responsibilities:Supervises and directs the efforts of the Complaints DepartmentReviews and approves complaints and complaint closure lettersResponsible for the coordination of worldwide complaint data into appropriate management reports, analyzing trend data associated....

- , 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

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