{"schemaVersion":"jobsearcher.job.v1","id":"db4b8ca5a61ef91d63eed352","url":"https://jobsearcher.com/jobs/db4b8ca5a61ef91d63eed352","canonicalUrl":"https://jobsearcher.com/jobs/db4b8ca5a61ef91d63eed352","title":"Quality Engineer","description":"Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.\nWe are looking to hire a Quality Engineer for our facility in Fort Wayne, Indiana!\nJob Scope:\nResponsible for owning and executing quality system processes in support of quality objectives. The Quality Engineer will utilize a data driven approach to define or improve quality systems, quality processes or overall product quality.\nDuties/Responsibilities:\nFacilitate or perform documented customer complaint investigations and complete any required customer responses.\nQuality lead for customer-based planning of new product launches, legacy product maintenance and customer related change control. Typical responsibilities include but are not limited to revising existing or creating; Control Plans, pFMEA, Gage R/R, final product acceptance inspection plans, and performing process capability studies in addition to meeting customer specific deliverables.\nPrimary quality representative for site supplier management and resolution of supplier nonconformances.\nSupport internal and external audits to maintain regulatory, customer and Avalign procedure compliance.\nCoordinate CAPA and SCAR investigations and closures in compliance with regulatory, customer and Avalign requirements.\nParticipate in Material Review Boards. Identify non-conformance trends and develop technical investigation plans.\nInvestigate and analyze customer/internal complaints for trends and potential improvements.\nResponsible for the development and execution of qualification and validation protocols. Summarizes results in reports.\nUtilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.\nEstablish and support a work environment of continuous improvement that aligns with Avalign’ s Quality Policy, Quality System, and the appropriate regulations for the areas they support.\nOther duties as assigned.\nCompetencies/Essential Functions:\nSelf-starter, open-minded, willing to learn new ideas, desire to drive change and improve current standards and be a team player\nGood interpersonal and communication skills both verbally and I writing with superiors, colleagues, and individuals inside and outside the company\nExperience leading or managing a quality group or department\nMeasurement system programming experience preferred\nPrevious medical device inspection experience\nAttention to detail\nAbility to work with little direct supervision\nKnowledge of ERP scheduling system\nKnowledge of Microsoft Excel, Word, and Outlook\nKnowledge of Minitab, gauge tracking software\nCAD and Lean/Six Sigma proficiency is a plus\nEducation and/or Experience:\nBachelor’s Degree in engineering discipline\nThree (3) plus years of relevant quality experience\nExperience with Medical Device manufacturing preferred\nWhat You'll Enjoy:\nCompetitive wage and benefits package\nVacation, make-up time, and immediate eligibility for paid holidays\nMedical, dental, and vision insurance\nLife and AD&D insurance, disability insurance\n401(k) Retirement Plan\nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.\nwww.avalign.com\nJob Type: Full-time\nBenefits:\n401(k)\nDental insurance\nHealth insurance\nPaid time off\nVision insurance\nSchedule:\n8 hour shift\nApplication Question(s):\nWhat interested you in the position at Avalign?\nWhat are your salary requirements?\nWork Location: In person","company":"Avaligntechnologies","rawCompany":"avaligntechnologies","city":"Fort Wayne","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-08-06T11:16:03.273Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.\nWe are looking to hire a Quality Engineer for our facility in Fort Wayne, Indiana!\nJob Scope:\nResponsible for owning and executing quality system processes in support of quality objectives. The Quality Engineer will utilize a data driven approach to define or improve quality systems, quality processes or overall product quality.\nDuties/Responsibilities:\nFacilitate or perform documented customer complaint investigations and complete any required customer responses.\nQuality lead for customer-based planning of new product launches, legacy product maintenance and customer related change control. Typical responsibilities include but are not limited to revising existing or creating; Control Plans, pFMEA, Gage R/R, final product acceptance inspection plans, and performing process capability studies in addition to meeting customer specific deliverables.\nPrimary quality representative for site supplier management and resolution of supplier nonconformances.\nSupport internal and external audits to maintain regulatory, customer and Avalign procedure compliance.\nCoordinate CAPA and SCAR investigations and closures in compliance with regulatory, customer and Avalign requirements.\nParticipate in Material Review Boards. Identify non-conformance trends and develop technical investigation plans.\nInvestigate and analyze customer/internal complaints for trends and potential improvements.\nResponsible for the development and execution of qualification and validation protocols. Summarizes results in reports.\nUtilize standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.\nEstablish and support a work environment of continuous improvement that aligns with Avalign’ s Quality Policy, Quality System, and the appropriate regulations for the areas they support.\nOther duties as assigned.\nCompetencies/Essential Functions:\nSelf-starter, open-minded, willing to learn new ideas, desire to drive change and improve current standards and be a team player\nGood interpersonal and communication skills both verbally and I writing with superiors, colleagues, and individuals inside and outside the company\nExperience leading or managing a quality group or department\nMeasurement system programming experience preferred\nPrevious medical device inspection experience\nAttention to detail\nAbility to work with little direct supervision\nKnowledge of ERP scheduling system\nKnowledge of Microsoft Excel, Word, and Outlook\nKnowledge of Minitab, gauge tracking software\nCAD and Lean/Six Sigma proficiency is a plus\nEducation and/or Experience:\nBachelor’s Degree in engineering discipline\nThree (3) plus years of relevant quality experience\nExperience with Medical Device manufacturing preferred\nWhat You'll Enjoy:\nCompetitive wage and benefits package\nVacation, make-up time, and immediate eligibility for paid holidays\nMedical, dental, and vision insurance\nLife and AD&D insurance, disability insurance\n401(k) Retirement Plan\nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.\nwww.avalign.com\nJob Type: Full-time\nBenefits:\n401(k)\nDental insurance\nHealth insurance\nPaid time off\nVision insurance\nSchedule:\n8 hour shift\nApplication Question(s):\nWhat interested you in the position at Avalign?\nWhat are your salary requirements?\nWork Location: In person","datePosted":"2026-08-06T11:16:03.273Z","dateModified":"2026-08-06T11:16:03.273Z","hiringOrganization":{"@type":"Organization","name":"Avaligntechnologies","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Fort Wayne","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"db4b8ca5a61ef91d63eed352"},"url":"https://jobsearcher.com/jobs/db4b8ca5a61ef91d63eed352"}}