{"schemaVersion":"jobsearcher.job.v1","id":"e39ea4476d689591ed52b1d7","url":"https://jobsearcher.com/jobs/e39ea4476d689591ed52b1d7","canonicalUrl":"https://jobsearcher.com/jobs/e39ea4476d689591ed52b1d7","title":"Quality Engineer","description":"Summary:\nQuality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.\n\nRoles & Responsibilities:\n\nExperience in a GMP and/or ISO regulated medical industry is required.\n\nAbility to analyze and present data that facilitates & drives decision making is required.\n\nThe ability to perform \"hands on \" troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.\n\nExperience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred\n\nTechnical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.\n\nAbility to read and interpret CMM and dimensional inspection reports.\n\nExperience with dimensional data analysis utilizing software (Excel or Minitab)\n\nExperience in Medical Standards and Quality process preferred.\n\nNew product launch experience from through full validation and commercial launch\n\nExperience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan\n\nEnsures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.\n\nPerformance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.\n\nStrong communication skills and ability to work well within a multidisciplinary team.\n\nProficient with GD&T and interpreting technical drawings.\n\nGreen or Black Belt Six Sigma certification preferred.\n\nRequirements:\n\nProcess Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)\n\nStatistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)\n\nMedical Device Quality Systems (GMP, ISO 13485, FDA Compliance)\n\nBachelor's in mechanical engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.\n\nRequired medical domain experience. Surgical Product and Implants experience preferred.\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Dayton","state":"OH","isRemote":false,"isActive":true,"createdAt":"2026-09-03T04:19:06.253Z","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":"Summary:\nQuality Engineer with 5+ years of experience in the medical device industry, specializing in quality, validation, and manufacturing engineering for surgical products and implants. Experienced in process validation (IQ/OQ/PQ), PFMEA/DFMEA, Gage R&R, SPC, DOE, risk assessments, and supplier qualification within GMP, ISO, and FDA-regulated environments. Proficient in GD&T interpretation, dimensional data analysis, root cause investigation, and new product commercialization. Strong analytical, problem-solving, and cross-functional collaboration skills with a proven ability to drive quality, compliance, and continuous improvement initiatives.\n\nRoles & Responsibilities:\n\nExperience in a GMP and/or ISO regulated medical industry is required.\n\nAbility to analyze and present data that facilitates & drives decision making is required.\n\nThe ability to perform \"hands on \" troubleshooting and problem solving is required Experience working in an FDA regulated environment is preferred.\n\nExperience working in operations supporting a production environment is preferred Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies (i.e. Measurement System Analysis, SPC, DOEs, Reliability, etc.) is preferred\n\nTechnical understanding of manufacturing equipment and processes is preferred Process Validation expertise is preferred.\n\nAbility to read and interpret CMM and dimensional inspection reports.\n\nExperience with dimensional data analysis utilizing software (Excel or Minitab)\n\nExperience in Medical Standards and Quality process preferred.\n\nNew product launch experience from through full validation and commercial launch\n\nExperience with PFMEA/DFMEA's, Gage R&R's, TMV's, Risk Assessments and Control Plan\n\nEnsures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.\n\nPerformance Component Qualification (Process Characterization, Process Capability Analysis, Test Method Validation, IQ, OQ, PQ, FAI) of new supplier manufactured components.\n\nStrong communication skills and ability to work well within a multidisciplinary team.\n\nProficient with GD&T and interpreting technical drawings.\n\nGreen or Black Belt Six Sigma certification preferred.\n\nRequirements:\n\nProcess Validation & Quality Engineering (IQ/OQ/PQ, TMV, PFMEA, Gage R&R)\n\nStatistical Analysis & Six Sigma (SPC, DOE, MSA, Minitab)\n\nMedical Device Quality Systems (GMP, ISO 13485, FDA Compliance)\n\nBachelor's in mechanical engineering or equivalent and have min. 5 years' experience working as a Quality, Validation and or Manufacturing Engineering role in a Medical Product industry required.\n\nRequired medical domain experience. Surgical Product and Implants experience preferred.\n\n#J-18808-Ljbffr","datePosted":"2026-09-03T04:19:06.253Z","dateModified":"2026-09-03T04:19:06.253Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Dayton","addressRegion":"OH","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e39ea4476d689591ed52b1d7"},"url":"https://jobsearcher.com/jobs/e39ea4476d689591ed52b1d7"}}