CAPA Quality Engineer

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      "postalCode": "15668",
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    "datePosted": "2026-05-29",
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    "description": "<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Job Responsibilities:</span></p>\n<ul>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Represent CAPAs during audits and CAPA Review Board meetings.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances. </span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> Independently produces and completes CAPA (Corrective and Preventive Action) records.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> Responsible for performing timely, detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis, and quality problem-solving.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Able to understand and analyze complex problems, including software and hardware design issues.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Strong Project Management skills, including ability to project manage all CAPA activities. Ability to analyze data and apply statistical techniques. </span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"> Excellent written and verbal communication skills</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Responsible for leading CAPA engineering activities like: assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.</span></li>\n<li><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Bachelor’s engineering degree with &gt; 5 years of related experience, or a Master’s degree with &gt; 3 years of related experience.</span></li>\n</ul>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">Position Details:</span><br><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\">• These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state.</span></p>\n<p><br></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><span style=\"color: inherit\">Benefits:</span></span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><br><span style=\"color: inherit\">Paid sick leave, Medical/Dental (optional), 401 (k) Retirement Plan (optional), Employer Paid Life Insurance, Employer Paid Short Term Disability, Optional Life Insurance.</span></span></p>\n<p><span style=\"font-family: arial, helvetica, sans-serif; font-size: 12pt\"><br><span style=\"color: inherit\">ELYON International, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.</span></span></p>",
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