{"schemaVersion":"jobsearcher.job.v1","id":"2e37e2e24c53e6dfebfd6587","url":"https://jobsearcher.com/jobs/2e37e2e24c53e6dfebfd6587","canonicalUrl":"https://jobsearcher.com/jobs/2e37e2e24c53e6dfebfd6587","title":"Quality Engineer","description":"Job Summary\nThis position will assist in performing the essential duties and responsibilities listed below as required by Tegra Medical ensuring that the customer product requirements and Tegra Medical requirements are met while meeting the requirements of the Tegra Medical quality policy and quality objectives established for the Tegra Medical ISO 13485:2016 quality management system, regulatory requirements, and environmental, health, and safety requirements.\nThe role of the Quality Engineer is to assist in the planning, executing, and finalizing projects according to strict deadlines and within budget. Specific functional areas include, but are not limited to, preparation and execution of protocols for performance qualifications and product characterizations for new product introductions, perform design transfer activities related to the product, processes, and measurement tools/methods (Gauge R&R). The Quality Engineer will also assist defining the project’s objectives and oversees quality assurance throughout its life cycle.\n\nRole and Responsibilities\nSupports the Quality organization and assist with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement.\nAssisting development, implementation, and continual improvement of the validation/qualification process(es).\nAssisting direction and management of the project development, day-to-day operational aspects of a project and scope.\nExperience with Statistics for validation, design of experiments, and capability analysis.\nExperience with Minitab or equivalent statistical software.\nSuperior written and oral communications skills.\nAssist planning and scheduling project timelines and milestones using appropriate tools.\nAssist development and delivering progress reports, proposals, requirements documentation, and presentations.\nAssist determining the frequency and content of status reports from the project team, analyze results, and troubleshoot problem areas.\nAssist to proactively manage changes in project scope, identify potential crises, and devise contingency plans.\nAssist to define project success criteria and disseminate them to involved parties throughout project life cycle.\nAssist building, developing, and growing any business relationships vital to the success of the project.\nAssists in customer audits and inspections conducted by regulatory organizations.\nAbility to effectively prioritize and execute tasks in a high-pressure environment .\nAbility to read blueprints, drawings, and printed documents along with inspection criteria supplied by the customer.\nAssist with determining measurement methods for new and existing products meeting industry requirements.\nAbility to plan, setup, and execute GR&R studies and develop reports.\nAbility to develop process flow diagrams, PFMEA’s, and inspection criteria for use in manufacturing.\nAssist with developing and maintaining quality metrics and communicating trends to all levels of the organization.\nPerform non-routing tasks as assigned by supervision.\nQualifications\nPrior experience in Quality Assurance or Regulatory compliance and in the medical device or related industry is preferred.\nExperience performing validation and qualification of equipment, processes and software in the medical device or related industry.\nExperience with ISO 13485:2016 standard and/or FDA Quality System Regulations and Environment, Health, & Safety regulations is a plus.\nEducation Requirements\nBachelor’s degree preferably in a technical field and a minimum of 4 years work experience, or equivalent combination of education and experience.\n\nPhysical Requirements:\nFrequent performing repetitive work.\nOccasional lifting (max. 40 lbs.)\nOccasional carrying (max. 40 lbs.)\nSubject to physical hazards from moving equipment and machine parts\nConstant safety glasses\nConstant full PPE\nFrequent standing\nOccasional sitting, walking, pushing, pulling, reaching.","company":"Tegra Medical","rawCompany":"tegra medical","city":"Hernando","state":"MS","isRemote":false,"isActive":false,"createdAt":"2026-07-31T11:11:45.327Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Job Summary\nThis position will assist in performing the essential duties and responsibilities listed below as required by Tegra Medical ensuring that the customer product requirements and Tegra Medical requirements are met while meeting the requirements of the Tegra Medical quality policy and quality objectives established for the Tegra Medical ISO 13485:2016 quality management system, regulatory requirements, and environmental, health, and safety requirements.\nThe role of the Quality Engineer is to assist in the planning, executing, and finalizing projects according to strict deadlines and within budget. Specific functional areas include, but are not limited to, preparation and execution of protocols for performance qualifications and product characterizations for new product introductions, perform design transfer activities related to the product, processes, and measurement tools/methods (Gauge R&R). The Quality Engineer will also assist defining the project’s objectives and oversees quality assurance throughout its life cycle.\n\nRole and Responsibilities\nSupports the Quality organization and assist with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement.\nAssisting development, implementation, and continual improvement of the validation/qualification process(es).\nAssisting direction and management of the project development, day-to-day operational aspects of a project and scope.\nExperience with Statistics for validation, design of experiments, and capability analysis.\nExperience with Minitab or equivalent statistical software.\nSuperior written and oral communications skills.\nAssist planning and scheduling project timelines and milestones using appropriate tools.\nAssist development and delivering progress reports, proposals, requirements documentation, and presentations.\nAssist determining the frequency and content of status reports from the project team, analyze results, and troubleshoot problem areas.\nAssist to proactively manage changes in project scope, identify potential crises, and devise contingency plans.\nAssist to define project success criteria and disseminate them to involved parties throughout project life cycle.\nAssist building, developing, and growing any business relationships vital to the success of the project.\nAssists in customer audits and inspections conducted by regulatory organizations.\nAbility to effectively prioritize and execute tasks in a high-pressure environment .\nAbility to read blueprints, drawings, and printed documents along with inspection criteria supplied by the customer.\nAssist with determining measurement methods for new and existing products meeting industry requirements.\nAbility to plan, setup, and execute GR&R studies and develop reports.\nAbility to develop process flow diagrams, PFMEA’s, and inspection criteria for use in manufacturing.\nAssist with developing and maintaining quality metrics and communicating trends to all levels of the organization.\nPerform non-routing tasks as assigned by supervision.\nQualifications\nPrior experience in Quality Assurance or Regulatory compliance and in the medical device or related industry is preferred.\nExperience performing validation and qualification of equipment, processes and software in the medical device or related industry.\nExperience with ISO 13485:2016 standard and/or FDA Quality System Regulations and Environment, Health, & Safety regulations is a plus.\nEducation Requirements\nBachelor’s degree preferably in a technical field and a minimum of 4 years work experience, or equivalent combination of education and experience.\n\nPhysical Requirements:\nFrequent performing repetitive work.\nOccasional lifting (max. 40 lbs.)\nOccasional carrying (max. 40 lbs.)\nSubject to physical hazards from moving equipment and machine parts\nConstant safety glasses\nConstant full PPE\nFrequent standing\nOccasional sitting, walking, pushing, pulling, reaching.","datePosted":"2026-07-31T11:11:45.327Z","dateModified":"2026-07-31T11:11:45.327Z","hiringOrganization":{"@type":"Organization","name":"Tegra Medical","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hernando","addressRegion":"MS","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2e37e2e24c53e6dfebfd6587"},"url":"https://jobsearcher.com/jobs/2e37e2e24c53e6dfebfd6587"}}