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Sr Quality Engineer Main Objective: Responsible for various Quality Assurance functions for manufacturing development of medical devices in the achievement of company goals. Design, develop, implement, and improve manufacturing processes to quality medical device products and systems. This position requires leadership skills, the willingness, and ability to mentor Quality Assurance team members and contributions beyond objectives and expected performance. Essential Duties and....


Sr QA Validation Engineer -Manufacturing Summary Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Main Objective: Responsible for supporting the Validation Manager with all process validation related support for....


Quality Engineering Manager Main Objective: Responsible for ensuring that the Manufacturing Quality System is effectively established, deployed, maintained, and continually improved. Works closely with Operations Management to drive and maintain world-class manufacturing operations and quality outcomes. Manages, directs, and mentors the efforts of QA Engineering and QA Technicians. Monitors and reports on the performance of the quality system to management and establishes the format and....


Regulatory Affairs Specialist Essential Duties and Responsibilities:With minimal supervision, prepares and writes 510(k) submissions and Letters-To-FileAct as the regulatory representative on product development teams for new and modified devicesDevelops the regulatory strategy for new and modified devices for the U.S.Reviews device changes to assess regulatory impactGathers information and data from other departments and external resources for regulatory submissions in both U.S. and....


Sr Systems Engineer 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. Recognized as a technical leader and resource. ESSENTIAL DUTIES AND RESPONSIBILITIES: Lead team efforts in establishing program design inputs and/or requirements, ensuring compliance to Company QMS and global standards and regulatory requirementsLead teams in the....


Sr. Product Development Engineer - Knee Arthroplasty Main Objective: Responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Essential Duties and Responsibilities:Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.Recommends alterations to development and design to improve quality of products and/or....


Senior Packaging Engineer Main Objective: Provides packaging engineering and related support to Design Engineering and when required, contract packaging suppliers. Determine and administer changes to improve overall package performance and/or cost reduction. Support and assist the companies packaging objectives. Essential Duties and Responsibilities:Using a CAD program, assist in the design and development of packaging components for medical devices as required per quality standards.Create and


Director of Operations 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 Corporate QA Director 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....


Manufacturing Engineering Manager Main Objective: Lead team to rapidly develop, implement and improve capable and cost effective manufacturing processes that produce quality products. Essential Duties and Responsibilities:Develop and utilize systematic and comprehensive methods and tools to accomplish objectivesVoice of the CustomerRequirements FlowUse ConditionsEngineering Concept Generation and SelectionProcess Development Robust EngineeringDesign for Manufacturability, Assembly, Inspection,


Senior Operations Manager Main Objective: Plans directs and coordinates all site manufacturing operations to effectively and profitably produce superior quality products ensuring on-time delivery. Leads cross-functional teams and provides project management to improve quality, process efficiency, labor deployment, and equipment utilization. Essential Duties and Responsibilities:Provides analysis and proposed plans regarding workforce utilization, space requirements, and workflow, and suggests....


Director- Operations Main Objective: To lead, oversee and provide direction to the appropriate manufacturing departments that will effectively and profitably meet or exceed the internal and /or external client’s expectations by providing superior quality products and services. Essential Duties and Responsibilities:Coordinates production in accordance with company policies, principles, and procedures with a goal for positioning this site for growth to an anticipated 1000 team members over the....


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....


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....


Manager - Quality Engineering Main Objective: Responsible for leading quality engineering team for design, development transfer, QA manufacturing and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Essential Duties and Responsibilities: Manages Quality Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design and operation support activities to provide timely and efficient flow of....


Program Manager Main Objective: The Program Manager is primarily responsible for translating the design needs of the Product Management and Design Groups into a product. From the delivery of initial prototypes to managing the handoff from design to manufacture of formal new products and all Operational activities related to it. This includes adhering to policies and procedures necessary to ensure efficient and effective execution of these projects. ESSENTIAL DUTIES AND RESPONSIBILITIES:Manages


Product Improvement Engineer MAIN OBJECTIVE: Manage and coordinate as assigned Sustaining Engineering tasks including design, engineering, documentation, manufacturability and qualification of the project as required. ESSENTIAL DUTIES AND RESPONSIBILITIES: Designs components or functional systems, and modifies existing designs to develop or improve products and facilitate manufacturing operations.Manage and coordinate as assigned Rapid Response Projects including the design, engineering,....


Project Manager, Process Engineering Main Objective: The Project Manager’s will own scope, schedule, and cost of various high impact projects. They serve as a fast response resource to resolve or mitigate problems and constraints and provide project management, technical guidance, and strategic direction to cross functional stakeholders in expediting execution of process improvement and validation activities. Essential Duties and Responsibilities:Identify opportunities for changing, improving....


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....


Principal Engineer Electrical It is preferred this person reside in Florida but could work company offices in from CA or MA. 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. Recognized as a technical leader and resource, particularly related to the design of electronic circuits and associated technologies. Provide technical....


Sr Design Assurance Engineer - Mechanical Main Objective: Responsible for interfacing and driving Design Assurance principles within engineering teams for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals. Essential Duties and Responsibilities:Lead design assurance efforts within product design and development for new product introduction projects with an emphasis in quality aspects....

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