{"schemaVersion":"jobsearcher.job.v1","id":"2ec0ff2405853e83a6dca077","url":"https://jobsearcher.com/jobs/2ec0ff2405853e83a6dca077","canonicalUrl":"https://jobsearcher.com/jobs/2ec0ff2405853e83a6dca077","title":"Quality Engineer","description":"Quality Engineer – Medical Device Industry\nLocation: Kennesaw, GA | On-site\nSalary: $70,000–$75,000\nEmployment Type: Full-Time\nSchedule: Monday–Friday, 8:00 AM–5:00 PM\nOpenwork is sourcing on behalf of our client, a growing organization in the medical device industry. We are seeking a Quality Engineer to join their Regulatory Affairs & Quality Assurance team and support quality activities across the product life cycle.\nAbout the Role\nThe Quality Engineer will support quality engineering activities from new product development and commercialization through sustaining changes. This role works closely with cross-functional teams on product quality, process development, validation, risk management, regulatory compliance, and continuous improvement.\nKey Responsibilities\nSupport the transfer of new products into production, including process validation activities such as PFMEA, IQ, OQ, and PQ.\nAssist with verification and validation test plans, protocols, and reports.\nSupport compliance with applicable FDA and regulatory requirements.\nReview product designs for manufacturability, reliability, testability, and quality requirements.\nParticipate in product risk management activities, including risk assessments, dFMEA, and risk management reports.\nSupport supplier quality, manufacturing quality, and customer complaint investigations.\nApply statistical tools and techniques to quality and process improvement initiatives.\nManage multiple projects, timelines, and deliverables while working with cross-functional teams.\nDevelop technical protocols, reports, procedures, and other quality documentation.\nParticipate in root cause investigations and corrective/improvement activities.\nPreferred Qualifications\n1–2+ years of experience in the medical device, life sciences, or related regulated industry.\nBachelor's degree in Engineering, Life Sciences, or a related field. An Associate's degree in Engineering Technology or a related technical discipline may be considered with relevant experience.\nExperience with ISO 14971 risk management.\nKnowledge of FDA Quality System Regulation, ISO 13485, and medical device regulatory requirements.\nExperience with IQ/OQ/PQ process validation.\nFamiliarity with DOE, SPC, capability analysis, GR&R, sampling plans, hypothesis testing, ANOVA, and other statistical methods.\nExperience with statistical software such as Minitab or similar tools.\nKnowledge of verification/validation, root cause analysis, and failure investigation.\nExposure to stability, biocompatibility, sterilization, or shipping/transport testing is a plus.\nFamiliarity with Lean and Six Sigma methodologies is preferred.\nStrong technical writing, communication, organization, and problem-solving skills.\nThe Process: If you are interested and qualified for this position, please APPLY NOW. If you have questions regarding the qualifications, please contact Jessika at JESSIKA.BRIGGS@OPENWORK.COM\n#OPWTXDH","company":"Openwork","rawCompany":"openwork","city":"Kennesaw","state":"GA","isRemote":false,"isActive":false,"createdAt":"2026-08-22T14:38:36.128Z","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":"Quality Engineer – Medical Device Industry\nLocation: Kennesaw, GA | On-site\nSalary: $70,000–$75,000\nEmployment Type: Full-Time\nSchedule: Monday–Friday, 8:00 AM–5:00 PM\nOpenwork is sourcing on behalf of our client, a growing organization in the medical device industry. We are seeking a Quality Engineer to join their Regulatory Affairs & Quality Assurance team and support quality activities across the product life cycle.\nAbout the Role\nThe Quality Engineer will support quality engineering activities from new product development and commercialization through sustaining changes. This role works closely with cross-functional teams on product quality, process development, validation, risk management, regulatory compliance, and continuous improvement.\nKey Responsibilities\nSupport the transfer of new products into production, including process validation activities such as PFMEA, IQ, OQ, and PQ.\nAssist with verification and validation test plans, protocols, and reports.\nSupport compliance with applicable FDA and regulatory requirements.\nReview product designs for manufacturability, reliability, testability, and quality requirements.\nParticipate in product risk management activities, including risk assessments, dFMEA, and risk management reports.\nSupport supplier quality, manufacturing quality, and customer complaint investigations.\nApply statistical tools and techniques to quality and process improvement initiatives.\nManage multiple projects, timelines, and deliverables while working with cross-functional teams.\nDevelop technical protocols, reports, procedures, and other quality documentation.\nParticipate in root cause investigations and corrective/improvement activities.\nPreferred Qualifications\n1–2+ years of experience in the medical device, life sciences, or related regulated industry.\nBachelor's degree in Engineering, Life Sciences, or a related field. An Associate's degree in Engineering Technology or a related technical discipline may be considered with relevant experience.\nExperience with ISO 14971 risk management.\nKnowledge of FDA Quality System Regulation, ISO 13485, and medical device regulatory requirements.\nExperience with IQ/OQ/PQ process validation.\nFamiliarity with DOE, SPC, capability analysis, GR&R, sampling plans, hypothesis testing, ANOVA, and other statistical methods.\nExperience with statistical software such as Minitab or similar tools.\nKnowledge of verification/validation, root cause analysis, and failure investigation.\nExposure to stability, biocompatibility, sterilization, or shipping/transport testing is a plus.\nFamiliarity with Lean and Six Sigma methodologies is preferred.\nStrong technical writing, communication, organization, and problem-solving skills.\nThe Process: If you are interested and qualified for this position, please APPLY NOW. If you have questions regarding the qualifications, please contact Jessika at JESSIKA.BRIGGS@OPENWORK.COM\n#OPWTXDH","datePosted":"2026-08-22T14:38:36.128Z","dateModified":"2026-08-22T14:38:36.128Z","hiringOrganization":{"@type":"Organization","name":"Openwork","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Kennesaw","addressRegion":"GA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2ec0ff2405853e83a6dca077"},"url":"https://jobsearcher.com/jobs/2ec0ff2405853e83a6dca077"}}