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  • Regulatory Affairs Professional 4  

    Cube hub
    - Middlesex County
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    Job Title -Regulatory Affairs Professional 4 Duration: 12 months-possi... Read More
    Job Title -Regulatory Affairs Professional 4 Duration: 12 months-possible to extend Location Newton MA 02466 Shift : 1 st Pay rate-on basis of exp-negotiable Description: As a Regulatory Affairs Specialist Consultant you will be responsible for: Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US market as well as markets outside of the US (e.g. Europe Asia). In collaboration with subject matter experts independently prepare and author regulatory documents such as Design Dossiers Technical Files Device License Applications Investigational Device Exemptions (IDE) and pre-market notifications such as De Novo. Support and manage interactions with regulatory bodies (e.g. FDA Notified Body) Support Clinical Affairs (Research) in Clinical Evaluation Reports Post Market Surveillance Reports as needed. Lead the reporting of these technical documents to regulatory bodies as required by internal quality procedures. Participate and support new product development teams by defining regulatory requirements for product development along with ensuring adherence to internal Design Control SOPs; Support clinical affairs and clinical operations as needed (i.e. periodic reporting of safety to regulatory agencies) Support document change control activities that require regulatory approval. Review validation protocols and reports to support regulatory submissions. Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the discipline as relevant to assigned projects. Ensure compliance with regulatory agencies and all applicable standards worldwide for legacy and new products. Work on complex challenges that require in depth knowledge of regulatory principles and practices. Other duties as assigned. R equired skills to have for the success of this role: Bachelors degree in a scientific discipline required Masters degree or higher preferred. Minimum of 15 years experience in strategic Clinical and Regulatory Affairs tactical executions (including authoring regulatory submissions and demonstrating favorable outcomes such as regulatory approvals) a must; Proficiency in ISOCFR820 (including Design Controls and Risk Analysis) EU MDR Regulation (EU) 2017/745 is a must. Experience in medium to high-risk devices with along with De Novo or PMA applications and demonstrated approvals are a must. Experience in generating updating and managing Clinical Evaluation Plans/Reports and Post Market Surveillance Plans/Reports is a must. Experience with authoring and managing Technical Files and Design Dossiers conforming with Europes Medical Device Regulation is a must. Proficiency and experience in rest of world regulatory submissions requirements for premarket approvals or clinical trial authorizations (e.g. Asia South America) are ideal. Experience in project management and associated project management tools (e.g. Microsoft Project) is a must. Knowledge and experience in clinical affairs including IDE submissions are ideal. Experience with complex electromechanical software controlled robotic systems AI SaMD neuro devices is ideal Experience with FDA inspection (QSIT) and Notified Body audits is required. Experience with FDA BIMO inspection is ideal. RAC-devices certificate preferred. Ability and willingness to work in a lean fast-paced environment. Willing to travel up to 5%. Key Skills Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing Read Less
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  • Sales &amp Marketing Community Manager I  

    Cube hub
    - Winnebago County
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    100% remote Job duration: 12 months job Title: Sales Marketing - Commu... Read More
    100% remote Job duration: 12 months job Title: Sales Marketing - Community Manager I Role offers offsite remote working arrangement from any US-based home location Adequate internet/Wi-Fi service is necessary to complete work duties Shifts vary between the hours of 8:00am-9:00pm CT Monday thru Friday depending on assigned schedule Role requires minimal weekend (consecutive Saturday Sunday) coverage between 9:00am-5:00pm CT depending on assigned schedule (rotating through extensive CM team) Engagement with multiple disciplines throughout the organization therefore must be able to professionally represent the Consumer Engagement team and our cohesive perspective Job Description: The community manager will manage owned social media channels engage with consumers in social media both proactively and reactively and will act as the external voice of the company and specific brands while simultaneously acting as the voice of the consumer internally. The value lies in the community manager serving as a hub and having the ability to connect personally with consumers (humanize the company) to shepherd and provide feedback to various departments internally (brand AMC consumer services quality legal IT etc.) and to be on the front line for spotting emerging risk in social channels. The community manager is responsible for overseeing multiple heaalthcare brands within a sector/category and ensuring that our consumers receive the most efficient integrated and effective experience available. An integral role of the brands presence on social media the community manager has practical knowledge leveraging brand voice in the form of culturally relevant social-native commenting this is not a social media strategist or campaigns and tactics development role Qualifications: Candidate should hold a bachelors degree preferably in a relevant discipline (i.e. communication marketing PR journalism or other relevant areas ) and/or demonstrated equivalent ability and experience in the targeted area Copywriting/editing experience for social content general engagement and risk management is required A minimum of 1-2 years of experience is typically expected in entering this position Experience with Sprinklr (or related social media management Read Less
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  • Manufacturing Technician  

    Cube hub
    - Frederick County
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    Description: Shift: Days Hours: 6am-6:30pm Location: Frederick MD Day... Read More
    Description: Shift: Days Hours: 6am-6:30pm Location: Frederick MD Day Shift- Brief Job Description: Operation of upstream / downstream / central services processing equipment according to established SOPs. Job Responsibilities (to include key result areas specific accountabilities tasks etc.) Operation of processing equipment according to established SOPs MPRs catch(err) Additional Details Does the position allow for the worker to be virtual/remote : No Critical Position : Yes Career Level : B External Job Title : (No Value) Key Skills Lean Manufacturing,Hand Tools,Basic Math,Math,Mechanical Knowledge,Assembly Experience,Computer Literacy,Schematics,cGMP,Clamp Truck,Programmable Logic Controllers,Manufacturing Employment Type : Full Time Experience: years Vacancy: 1 Read Less
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  • Engineering Technician I Product Engineering Support  

    Cube hub
    - Rock Island County
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    Description : Position Title Paint Lab Tech Requires person to work on... Read More
    Description : Position Title Paint Lab Tech Requires person to work onsite. Metatarsal shoes required. 1st; shift - some flexibility on exact hours. Engineering Technician I Provides support for and/or assistance with materials engineering testing and lab operations. Technicians at this level typically perform appropriate tests using existing procedures for process control and Paint Lab performance testing. Provides routine analysis for materials testing and assists with problem identification root cause analysis corrective action tracking and verification/validation test plan development. Provides guidance on topics related to test procedures status and results to engineers and support personnel. Requires knowledge and understanding of lab testing equipment and technologies. Duties: Operates and maintains lab equipment to perform a variety of routine materials engineering tests. Assists test customers in drafting test plans/matrices by incorporating standard test offerings into Excel. Maintains testing systems and completes lab work queues to ensure that lab tests are completed on time. Maintains workflow and adjusts priorities based on urgent requests. Monitors and participates in the implementation of improvements for lab operations. Creates lab operations test schedules SOPs and other daily protocols of similar nature. Maintains operation of all test equipment mechanical and chemical to ensure that painted parts are tested appropriately and are assessed in comparison to Enterprise specifications. Supports the paint lab and assists the failure analysis process by preparing parts for test ordering supplies maintaining equipment executing standard paint tests to ensure compliance to quality standards. Communicates and/or maintains engineering data or other testing information to the appropriate personnel and/or SharePoint database. Uses knowledge of tests to assist others help explain testing and process in lab tours as well as all virtual communication methods such as Microsoft Teams meetings instant message and email. Data entry preparation of test specimens setup of testing equipment and running tests per documented lab procedures. The ability to quickly adapt to frequently changing work priorities is a must. The candidate must also be able to adhere to a strict schedule as certain responsibilities within this position are time sensitive. Microsoft Office computer software (Excel Word PowerPoint) proficiency is required. Requires knowledge on how to manipulate data text images tables and general formatting. Ability to solve problems learn new topics and develop/organize new projects using foundational training and resources with limited oversight. Preferred qualifications: associates degree or higher in a STEM / engineering tech related field and/or actively pursuing a degree in a STEM / engineering tech field. Key Skills Hospital Experience,Hotel Experience,Taleo,Calibration,Pool Maintenance,Maintenance Management,Maintenance,Quality Control,Boiler,Oil Read Less
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  • Information Technology Technology Lead – Coupa Source to Pay  

    Cube hub
    - Fulton County
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    Job Description: Technology Lead Coupa Source to Pay Position Summary:... Read More
    Job Description: Technology Lead Coupa Source to Pay Position Summary: As part of Digital Core Transformation team you will be responsible for the design and implementation of Coupa and surround system (SAP S4Hana) capabilities supporting Procurement business processes. We re looking for someone who has experience supporting teams project management and values strong vendor partnerships. This is your opportunity to experience working cross-culturally in a global setup with peers leaders must be a constructive challenger/assertive Experience in creating/ reviewing functional specifications for custom enhancements Ability to create and execute outcome-oriented strategies and build/sustain meaningful business relationships Solid analytical and problem-solving skills Ability to work effectively and collaboratively with internal business technical and external consulting teams Ability to work independently in a fast-paced environment Ability to manage projects and teams including working with vendor partners Experience to work in a global setup with peers leaders Read Less
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  • Electrical Developer 4  

    Cube hub
    - Travis County
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    Description: Sr. Electrical Engineer Located in Texas at a site that s... Read More
    Description: Sr. Electrical Engineer Located in Texas at a site that supports both R remote work is not standard. Travel Requirements No travel required for any of the roles. Senior Electrical Engineer Minimum 7 years of electrical engineering experience. Strong background in test engineering test development and practical hands-on work. Medical device experience is a plus but not mandatory. Compensation Interview Process Three rounds: Screening interview with hiring manager Second interview with additional team members Team panel interview (especially for EE and PM roles). Culture fit is a key consideration. Responsibilities Support the client Healthineers (VIS) Austin TX site as an electrical engineer for components devices systems software and test system for commercial products product enhancements and new product development. Performing electrical design activities including but not limited to component selection circuit design/simulation prototype evaluation unit-level testing lifecycle testing system integration testing drawing/document creation and modification and execution of Engineering Change Orders within SAP for hardware firmware and embedded software components. Continuously improving quality by addressing manufacturing and field non-conformities through troubleshooting and root cause analysis with the use of electrical test equipment and custom test sets. Skills/Attributes: Strong electrical design skills with schematic and engineering analysis capabilities. Excellent written verbal and organizational skills including maintaining thorough and accurate engineering documentation required for medical devices and the ability to effectively communicate to all levels of engineering and management. Outstanding interpersonal skills to work with cross-functional internal and external teammates in the mechanical software quality manufacturing supply chain and service organizations. Self-motivated and detail-oriented to produce high quality results in a timely fashion. Understanding of electronic assembly fabrication and manufacturing processes with experience collaborating with contract manufacturing suppliers for new product introduction (NPI). Knowledge of best practices for design for manufacturing serviceability and reliability. Familiarity with electronic product development in a highly regulated environment. Requirements for success in this role: Bachelors or Masters degree in Electrical Engineering or equivalent discipline required. 5 years of relevant experience in the design and manufacturing of custom electrical assemblies. Medical device experience is a plus Proven track record of contribution to multiple products projects and processes taken from concept to fruition. Position Description: * Develops electrical components. * Tests electrical components.* Identifies and selects components materials parts and semi-products appropriate for electrical system design. * Creates electrical models and tolerance analyses to simulate electrical design concepts. * Calculates and creates final layout including documentation and specification for parts assemblies or finished products.* Maintains technical product files. * Analyzes existing development procedures and suggest improvements. * Upgrades the design of existing devices by adding electrical elements. * Analyzes localization requirements and designs/adapts products and solutions accordingly. Impacts: Is expected to adopt existing concepts methodologies order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements. Key Responsibilities: Senior Professional Positions which need senior professional expertise with extensive functional commercial and/or technical knowledge in an area of competence. They integrate analysis development testing and implementation. They interpret and functionally influence policy and guidelines in their area of business / technology and develop processes and systems to deliver functional objectives. They typically plan own work according to targets agreed within a quarterly up to an annual cycle by integrating resources in a project driven environment. They provide functional advice and guidance to colleagues and customers. A chartered professional qualification or equivalent is typically associated with grades (though not necessary). Experience: 8-10 years. Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem-solving competence. Improves existing processes and approaches Enable Skills-Based Hiring No $(function() $(.qualPlaceHolder).each(function() if($(this).parents(#jsLegend).length ! 1 $(this).find(ul).length 0) var requested $(this).attr(requested); var presented $(this).attr(presented); var dynamicId $(this).attr(id); var text $(this).attr(text); var readOnly ($(this).attr(edit) true); var flexibleScaleLevels $(this).attr(flexibleScaleLevels); var flexibleScaleLevelNames $(this).attr(flexibleScaleLevelNames); new ( element: $(this) readOnly: readOnly requested: requested presented : presented dynamicId : dynamicId text : text flexibleScaleLevels : flexibleScaleLevels flexibleScaleLevelNames : flexibleScaleLevelNames ).initialize(); ) ); Qualification Additional Details Does this worker qualify for overtime : Yes Scorecard Category : Engineering Commercial Title : Sr Electrical Engineer Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption. Is this position for a pre-identified (PAYROLLED) candidate : RECRUITED If this is a pre-identified (PAYROLLED) candidate please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidates resume Will this contingent worker require a computer or systems access or utilize a timeclock : Yes Time System : Fieldglass Timeclock/Shift : Fieldglass1 Enter Shift Start and End Time : 8:00 AM to 5:00PM Is there potential for this to convert to a full time position : Yes Non-Employee Class : Temporary Agency Worker Will the worker be required to travel for client : No Is there potential for this assignment to be extended beyond 13 weeks : Yes Type of assignment : Full-time Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start not applicable in the following states: Alabama Florida Iowa Kansas Montana North Dakota Tennessee Texas and Utah. States subject to change Qualification Assessment Must Have Admin CCWSCSVCC No Key Skills CCTV,Computer Science,Corporate Marketing,E Learning,Arabic English Translation Employment Type : Full Time Experience: years Vacancy: 1 Read Less
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  • Laboratory Technician 1  

    Cube hub
    - Whitley County
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    Description: Notes from Intake call: Job Position Details: 1. Reason f... Read More
    Description: Notes from Intake call: Job Position Details: 1. Reason for Hiring: New position. 2. Work Location: Must work onsite. 3. Travel Requirements: No travel required. 4. Experience Required: Minimum 0 years. 5. Start Date: target start date beginning of the month for new hire trainings. 6. Interview Process: 1st: Phone screening. 2nd: Onsite interview. 3rd: Teams interview with regional manager. 7. Pay Rate: $19.00 8. Work Hours: Flexible hours; early start time early as 6AM sometimes earlier still an 8-hour shift. Must-Have Skills: 1. Organization 2. Attention to detail 3. Time management 4. Effective communication 5. Ability to read listen and understand technical procedures 6. Ability to lift to 100 lbs occasionally most items 65-75 lbs cases with handles Nice-to-Have Skills: 1. Logistics experience 2. Customer service acumen 3. Ability to answer phones and speak with customers vendors. Success Metrics: Site cleanliness Customer communication Accurate inventory receipts Additional Information: No college degree required high school diploma or equivalent Military experience Cleaning tasks involved Comfortable working in a radiation environment (training provided) GMP EHS training for lifting and moving cases (30 days total) Experience in Receiving materials verifying shipments basic PC skills learning to read a meter Lab Assistant (LA) - Position Overview As a Lab Assistant you will facilitate the daily operations of the facility through assisting the production staff with administrative and housekeeping tasks which are crucial to maintain excellent customer service and site inspection readiness. This job involves working nightshift in a manufacturing setting and occupational exposure to radiation. As a Lab Assistant you are responsible for: Ability to work independently Ability to read listen and understand technical direction policies and procedures Effective communication skills Proven ability to work under pressure Understanding and awareness of radiation safety quality var presented $(this).attr(presented); var dynamicId $(this).attr(id); var text $(this).attr(text); var readOnly ($(this).attr(edit) true); var flexibleScaleLevels $(this).attr(flexibleScaleLevels); var flexibleScaleLevelNames $(this).attr(flexibleScaleLevelNames); new ( element: $(this) readOnly: readOnly requested: requested presented : presented dynamicId : dynamicId text : text flexibleScaleLevels : flexibleScaleLevels flexibleScaleLevelNames : flexibleScaleLevelNames ).initialize(); ) ); Qualification Additional Details Geographic Min and Max Pay Rates : Laboratory Technician 1SCMin Pay: $19.99 / Max Pay Rate: $24.98 Does this worker qualify for overtime : Yes Scorecard Category : Professional Commercial Title : Lab Assistant Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption. Is this position for a pre-identified (PAYROLLED) candidate : RECRUITED If this is a pre-identified (PAYROLLED) candidate please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidates resume Will this contingent worker require a computer or systems access or utilize a timeclock : Yes Time System : Fieldglass Timeclock/Shift : NA - Time is not tracked in any systemNA Enter Shift Start and End Time : 05:00 to 13:00 EST Is there potential for this to convert to a full time position : Yes Non-Employee Class : Temporary Agency Worker Will the worker be required to travel for Siemens : No Is there potential for this assignment to be extended beyond 13 weeks : Yes Type of assignment : Full-time Will this position require a DEA background check clearance : No Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start not applicable in the following states: Alabama Florida Iowa Kansas Montana North Dakota Tennessee Texas and Utah. States subject to change Qualification Assessment Must Have Admin CCWSCSVCC No Key Skills Anti Money Laundering,Cluster,AJAX,Jpa,Ethernet,Fire And Safety Engineering Employment Type : Full Time Experience: years Vacancy: 1 Read Less
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  • Laboratory Technician 1  

    Cube hub
    - Tulsa County
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    Description: Notes from Intake call: Job Position Details: 1. Reason f... Read More
    Description: Notes from Intake call: Job Position Details: 1. Reason for Hiring: New position. 2. Work Location: Must work onsite. 3. Travel Requirements: No travel required. 4. Experience Required: Minimum 0 years. 5. Start Date: target start date beginning of the month for new hire trainings. 6. Interview Process: 1st: Phone screening. 2nd: Onsite interview. 3rd: Teams interview with regional manager. 7. Pay Rate: $19.00 8. Work Hours: Flexible hours; early start time early as 3AM-11AM sometimes earlier still an 8-hour shift. Must-Have Skills: 1. Organization 2. Attention to detail 3. Time management 4. Effective communication 5. Ability to read listen and understand technical procedures 6. Ability to lift to 100 lbs occasionally most items 65-75 lbs cases with handles Nice-to-Have Skills: 1. Logistics experience 2. Customer service acumen 3. Ability to answer phones and speak with customers vendors. Success Metrics: Site cleanliness Customer communication Accurate inventory receipts Additional Information: No college degree required high school diploma or equivalent Military experience Cleaning tasks involved Comfortable working in a radiation environment (training provided) GMP EHS training for lifting and moving cases (30 days total) Experience in Receiving materials verifying shipments basic PC skills learning to read a meter Lab Assistant (LA) - Position Overview As a Lab Assistant you will facilitate the daily operations of the facility through assisting the production staff with administrative and housekeeping tasks which are crucial to maintain excellent customer service and site inspection readiness. This job involves working nightshift in a manufacturing setting and occupational exposure to radiation. As a Lab Assistant you are responsible for: Ability to work independently Ability to read listen and understand technical direction policies and procedures Effective communication skills Proven ability to work under pressure Understanding and awareness of radiation safety quality var presented $(this).attr(presented); var dynamicId $(this).attr(id); var text $(this).attr(text); var readOnly ($(this).attr(edit) true); var flexibleScaleLevels $(this).attr(flexibleScaleLevels); var flexibleScaleLevelNames $(this).attr(flexibleScaleLevelNames); new ( element: $(this) readOnly: readOnly requested: requested presented : presented dynamicId : dynamicId text : text flexibleScaleLevels : flexibleScaleLevels flexibleScaleLevelNames : flexibleScaleLevelNames ).initialize(); ) ); Qualification Additional Details Geographic Min and Max Pay Rates : Laboratory Technician 1OKMin Pay: $21.04 / Max Pay Rate: $26.30 Does this worker qualify for overtime : Yes Scorecard Category : Professional Commercial Title : Lab Assistant Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption. Is this position for a pre-identified (PAYROLLED) candidate : RECRUITED If this is a pre-identified (PAYROLLED) candidate please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidates resume Will this contingent worker require a computer or systems access or utilize a timeclock : Yes Time System : Fieldglass Timeclock/Shift : NA - Time is not tracked in any systemNA Enter Shift Start and End Time : 03:00AM - 11:00AM Is there potential for this to convert to a full time position : Yes Non-Employee Class : Temporary Agency Worker Will the worker be required to travel for Siemens : No Is there potential for this assignment to be extended beyond 13 weeks : Yes Type of assignment : Full-time Will this position require a DEA background check clearance : No Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start not applicable in the following states: Alabama Florida Iowa Kansas Montana North Dakota Tennessee Texas and Utah. States subject to change Qualification Assessment Must Have Admin CCWSCSVCC No Key Skills Anti Money Laundering,Cluster,AJAX,Jpa,Ethernet,Fire And Safety Engineering Employment Type : Full Time Experience: years Vacancy: 1 Read Less
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  • Production Operator 1  

    Cube hub
    - Lake County
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    Description: FULL TIME: No. of hours: 40 hrs. per week with possibilit... Read More
    Description: FULL TIME: No. of hours: 40 hrs. per week with possibility of OT 6:00 am-2:30pm M-F Safety Shoes required Start Date ASAP Make a note:---It is better if we narrow people with hands on experience in assembly. The Buffalo Grove site has agreed to cover the fees for safety shoes required for their Light Industrial (Material Handler-Production Coordinator) positions. The max amount is $150.00. The receipt can be submitted against the work order once the worker starts as an Expense Report. Again a receipt is required upon submissions into Fieldglass once the worker begins. Should you have an interview requested the Supervisor is requesting they use a side entrance with a blue canopy------tell them to sign in at the side employee entrance with a blue canopy over it. KEY DETAILS We are looking for someone who has some building experience Need Dependable Transportation We need someone that can also lift up to 25lbs Be ab le to work on their feet Can work by themselves or with others. Good Attitude Follows Directions and open to change Can work with their hands (Previous manufacturing Food Service working on cars ect ) Worked in a fast-paced environment. Can Learn Quickly and repeat what was learned. Good attendance. I. Basic Function Performs assembly test and packaging of electronic and mechanical products to prescribed quality and production standards and in accordance with ISO procedures. II. Essential Duties Manufactures products using visual aids written and verbal work instructions and procedures. Moves parts and materials as needed to maintain an orderly material flow. Rotates between operations within a work cell as well as between departments. Prepares work cell and/or department records. Notifies appropriate personnel if process/method is out of compliance. III. Knowledge Skills Read Less
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