דרושים United States, Noblesville

• Comply with all Quality Management System requirements and applicable laws/regulations

• Properly utilize controlled, released documentation to perform all work tasks and processes

• Meet and maintain all required training records and comply with all site safety policies

• Evaluate and identify damaged components, order replacement parts, and create work orders

• Disassemble, systems, clean all components, and repair/replace damage parts

• Complete any required service corrective actions and system software/hardware upgrades

• Reassemble systems and install required options and accessories

• Verify correct system operation through diagnostic and functional tests

• Record all test results and update Device History Records for each piece of equipment

• Identify, segregate, and disposition/redirect product that fails acceptance criteria

• Maintain accurate inventory records including status/location of parts and systems

• Maintain tools and test equipment properly and ensure calibrations are complete

• Drive product quality by identifying manufacturing issues and assist with corrections

• Work with engineers, team, and site leaders to improve process quality and efficiency

• Focus on improving on-time delivery and overall customer outcomes/experience

• High School Diploma or local equivalent and 2 or more years of relevant experience

• Ability to communicate, receive, and understand written and verbal instructions in English

• Flexibility to work both independently and within a team, with varied daily tasks/responsibilities

• Excellent attendance, accountability, teamwork, personal initiative, and work ethic

• Excellent time management skills, desire to learn, and flexible approach to daily work tasks

• Demonstrated attention to detail and focus on product quality and safe working practices

• Associate degree or higher in technology or engineering related discipline

• Previous experience in a manufacturing or service role in a regulated industry (Medical Device, etc.)

• Inspect and process materials according to the SOP (Standard Operating Procedure).

• Physically move materials from one location to another using hand trucks or forklifts.

• Physically and systematically receive/deliver individual release orders to internal and external services, quantify and verify inventory.

• Process products against purchase orders and work orders using an electronic management system.

• Collaborate with relevant logistics and production staff to mitigate/prevent stockouts.

• Manage/control important documents necessary for the recording, allocation, and distribution of a variety of regulated products.

• Conduct cycle audits and physical inventory according to the schedule.

• Participate in the reconciliation of inventory discrepancies and report discrepancies to the Team Leader.

• Comply with environmental, health, and safety (EHS) regulations and policies and quality system requirements.

• Read and follow work instructions and bill of materials.

• Perform other assigned tasks and/or special projects.

Quality Objectives:

• Know and understand product recalls, concessions, non-conforming products, material identification and segregation, document configuration control, good documentation practices, requirements related to approved suppliers/Sourcing department, and DMR/DHR requirements associated with this type of position/function.

• Know and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations for this type of position/function.

• Complete all scheduled Quality and Compliance training on time.

• Identify and report any quality or compliance issues and take immediate appropriate corrective actions.

• Bachelor's degree or Associate's degree OR High School Diploma / GED with 2+ years of relevant work experience

• Proficiency in the local language (reading, writing, and speaking).

• Excellent knowledge of basic mathematics.

• Ability to communicate and work with others.

• Basic computer knowledge.

• Handling skills.

• Ability to use automatic lifting devices.

• Developing in-depth knowledge of a technical discipline. Uses prior experience and acquired technical expertise to execute policy/strategy.

• In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

• Uses some level of judgment and has ability to propose different solutions outside of set parameters but with guidance. Uses prior experience and on-the-job training to solve straightforward tasks. Has access to technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

• A job at this level is likely to be an individual contributor with proven interpersonal skills or an early people leader who can hire and develop talent. Provides informal guidance to new team members

• Responsible for releasing new product to the floor including NPI (New Product Introduction) documentation.

• Oversees the production process removing obstacles while ensuring compliance and driving improvements.

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in service, manufacturing or remanufacturing)

• Strong oral and written communication skills. Ability to communicate in local language. (English)

• Demonstrated ability to analyze and resolve problems.

• Ability to document, plan, market, and execute programs.

• Established project management skills.

• High School Diploma or local equivalent and 2 or more years of relevant experience
• Ability to communicate, receive, and understand written and verbal instructions in English
• Flexibility to work both independently and within a team, with varied daily tasks/responsibilities
• Excellent attendance, accountability, teamwork, personal initiative, and work ethic
• Excellent time management skills, desire to learn, and flexible approach to daily work tasks
• Demonstrated attention to detail and focus on product quality and safe working practices
• Demonstrated capabilities in 3 or more of the Key Skills listed below

Preferred Qualifications:

• Associate degree or higher in technology or engineering related discipline
• Previous experience in a manufacturing or service role in a regulated industry (Medical Device, etc.)
• Demonstrated capabilities in all Key Skills listed below

Responsibilities Include:

• Comply with all Quality Management System requirements and applicable laws/regulations
• Properly utilize controlled, released documentation to perform all work tasks and processes
• Meet and maintain all required training records and comply with all site safety policies

• Evaluate and identify damaged components, order replacement parts, and create work orders

• Disassemble, systems, clean all components, and repair/replace damage parts
• Complete any required service corrective actions and system software/hardware upgrades
• Reassemble systems and install required options and accessories
• Verify correct system operation through diagnostic and functional tests
• Record all test results and update Device History Records for each piece of equipment
• Identify, segregate, and disposition/redirect product that fails acceptance criteria
• Maintain accurate inventory records including status/location of parts and systems
• Maintain tools and test equipment properly and ensure calibrations are complete
• Drive product quality by identifying manufacturing issues and assist with corrections
• Work with engineers, team, and site leaders to improve process quality and efficiency
• Focus on improving on-time delivery and overall customer outcomes/experience

• Test production assemblies and sub-assemblies for correct operation and compliance to performance specifications
• Interfaces with other departments in the execution of duties to ensure the orderly flow of material and information
• Construct and assist in evaluating engineering models
• Perform basic trouble shooting encompassing multiple variables and unknowns to achieve root cause analysis and problem resolution. Conduct experiments and diagnostic tests, as required to draw conclusions
• Perform software and hardware evaluation and implement plans using knowledge of product, system operation, intermodule interactions, engineering tolls, and interactive software tools as required
• Utilize basic technical communications throughout the new product cycle to improve internal models and/or externally sourced components in terms of system performance, reliability, functionality, and serviceability
• Provide evaluation, constructive feedback and leadership in the development of internal and external engineering, manufacturing, or service documentation
• Develop and execute training plans as required. Provide technical expertise and repair instruction for issues on the line.
• Provide strong individual contributions in the context of achieving team goals
• Provide technical assistance by telephone or in person to customers, field service personnel, or suppliers
• Comply with EHS regulations and policies
• General direction is given in the execution of job related activities

Required Qualifications:

• Bachelor’s degree in Manufacturing, Engineering or Technology related fields
• Associates degree, or a High School diploma and 2 years technical experience
• Proficiency to logically troubleshoot at subsystem and system level, using identifiable problem-solving techniques
• Ability to draw accurate conclusions from test data, malfunctions, or deviations, and assist with corrections to the existing design or process
• Proficiency to understand and interpret basic written technical information
• Demonstrated ability to work well with limited direction and information
• Ability to communicate using English (or local language)

Other :

• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type / position.
• Complete all planned Quality & Compliance training within the defined deadlines.
• Identify and report any quality or compliance concerns and take immediate corrective action as required.
• Knowledge and understanding of production process, work instructions, documentation configuration control, non-conforming & rework documentation requirements and operates within them to ensure that a device conforms to it’s specification.
• Aware of and comply with Stop Order, Concessions, ESD, Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position
• Experience repairing a wide variety of ultrasound models and BT levels.
• Experience training other people on repair tasks (preferably related to ultrasound).