{"schemaVersion":"jobsearcher.job.v1","id":"2e6ec2488c7b921f72c1a885","url":"https://jobsearcher.com/jobs/2e6ec2488c7b921f72c1a885","canonicalUrl":"https://jobsearcher.com/jobs/2e6ec2488c7b921f72c1a885","title":"Operations Quality Engineer II","description":"Salary Range: $80,000.00 To $100,000.00 Annually\n\nJob Summary\nSupport the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.\n\nKey Responsibilities\n\nFunction as the operation’s quality representative during the execution of engineering projects.\n\nResponsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.\n\nNCMR and CAPA investigation and reports, including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs.\n\nParticipate in cross-functional teams for the review and disposition of nonconforming products or components.\n\nParticipate in cross-functional teams to develop and assist in maintenance of Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).\n\nPrepare and review documentation with a high degree of accuracy, completeness, and effectiveness.\n\nParticipate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols. Provide guidance on Product Requirements compliance.\n\nProvide guidance and direction for sample size and statistical analysis of Verification and Validation testing.\n\nParticipate in Design Reviews and FMEA Reviews.\n\nParticipate in complaint investigation. Ensure investigations are thoroughly documented.\n\nProvide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.\n\nAssist in training of Special Work Orders, Receiving Inspection Processes, and FAIs as required\n\nOther duties as assigned.\n\nQualifications\n\nRequires a B.S. degree in Science, Engineering or Technology or associated fields.\n\n3-5 years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.\n\n3-5 years’ experience in the medical device industry.\n\nOR associate’s degree, with 10 years’ experience in Quality Assurance.\n\nWorking knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).\n\nWorking knowledge of new product design and development in medical devices.\n\nWorking knowledge of the application of risk management, include PFMEA.\n\nExcellent organizational and interpersonal skills working in a cross-functional teams.\n\nAbility to organize and prioritize workflow across multiple projects to meet established time frames and schedules.\n\nKnowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications.\n\nThis job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be a complete list of all activities, tasks and skills required of employees in this position.\n\n#J-18808-Ljbffr","company":"Evolving Solution Services","rawCompany":"evolving solution services","city":"Brooklyn Park","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-07-03T03:16:03.542Z","occupations":[{"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"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"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"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Operations Quality Engineer II","description":"Salary Range: $80,000.00 To $100,000.00 Annually\n\nJob Summary\nSupport the Quality Management System (QMS) organization. Work with design and manufacturing teams, completing operations quality activities. Assignments include use of quality engineering concepts including, but not limited to, design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement activities. Ensure desired design and product performance requirements are met in compliance with applicable regulatory, customer, and internal requirements. Skills in other technical areas such as verification testing, and sterilization validation are desired. Engage in routine daily activities such as First Article Inspections (FAI), CAPA, NCMR, change order review, and training.\n\nKey Responsibilities\n\nFunction as the operation’s quality representative during the execution of engineering projects.\n\nResponsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.\n\nNCMR and CAPA investigation and reports, including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and suppler CAPAs.\n\nParticipate in cross-functional teams for the review and disposition of nonconforming products or components.\n\nParticipate in cross-functional teams to develop and assist in maintenance of Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA, PFMEA, and Risk Management Report).\n\nPrepare and review documentation with a high degree of accuracy, completeness, and effectiveness.\n\nParticipate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols. Provide guidance on Product Requirements compliance.\n\nProvide guidance and direction for sample size and statistical analysis of Verification and Validation testing.\n\nParticipate in Design Reviews and FMEA Reviews.\n\nParticipate in complaint investigation. Ensure investigations are thoroughly documented.\n\nProvide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.\n\nAssist in training of Special Work Orders, Receiving Inspection Processes, and FAIs as required\n\nOther duties as assigned.\n\nQualifications\n\nRequires a B.S. degree in Science, Engineering or Technology or associated fields.\n\n3-5 years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.\n\n3-5 years’ experience in the medical device industry.\n\nOR associate’s degree, with 10 years’ experience in Quality Assurance.\n\nWorking knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).\n\nWorking knowledge of new product design and development in medical devices.\n\nWorking knowledge of the application of risk management, include PFMEA.\n\nExcellent organizational and interpersonal skills working in a cross-functional teams.\n\nAbility to organize and prioritize workflow across multiple projects to meet established time frames and schedules.\n\nKnowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) including the ability to read and understand prints and specifications.\n\nThis job description is intended to describe the general nature and level of work being performed by employees assigned to this position. It is not intended to be a complete list of all activities, tasks and skills required of employees in this position.\n\n#J-18808-Ljbffr","datePosted":"2026-07-03T03:16:03.542Z","dateModified":"2026-07-03T03:16:03.542Z","hiringOrganization":{"@type":"Organization","name":"Evolving Solution Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Brooklyn Park","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"2e6ec2488c7b921f72c1a885"},"url":"https://jobsearcher.com/jobs/2e6ec2488c7b921f72c1a885"}}