{"id":38893,"date":"2023-10-04T11:02:52","date_gmt":"2023-10-04T11:02:52","guid":{"rendered":"https:\/\/oradeo.com\/job\/quality-engineer\/"},"modified":"2023-10-04T11:02:52","modified_gmt":"2023-10-04T11:02:52","slug":"quality-engineer","status":"publish","type":"job_listing","link":"https:\/\/oradeo.com\/job\/quality-engineer\/","title":{"rendered":"Quality Engineer"},"content":{"rendered":"<p><strong><u>Quality Engineer<\/u><\/strong><\/p>\n<ul>\n<li><strong>Leading Medical Device Company in the Sligo <\/strong><\/li>\n<li><strong>Excellent career progression opportunities along with a generous package.<\/strong><\/li>\n<\/ul>\n<p><strong>Oradeo Recruitment<\/strong>&nbsp;is presently seeking interest for a&nbsp;<strong>Quality Engineer<\/strong> in our clients Division&nbsp;located in Sligo.&nbsp; This position comes with an excellent remuneration package and a clear path for career growth.<\/p>\n<p><strong>Duties and Responsibilities:<\/strong><\/p>\n<ul>\n<li>Provide technical quality support to Project Manager, Design Engineers, Production manager and clients.<\/li>\n<li>Work closely with Engineering team and the client to establish and maintain compliant product specifications.<\/li>\n<li>Quality review of process validation plan, protocols, and reports.<\/li>\n<li>Co-ordinate and contribute to the generation and maintenance of compliant product risk management files.<\/li>\n<li>Issue, review, and release of lot records to manufacturing.<\/li>\n<li>Co-ordinate and review of testing and release of sterilise product.<\/li>\n<li>Quality review of SOP&rsquo;s, Work instruction&rsquo;s, template&rsquo;s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures.<\/li>\n<li>Review and approve product change controls.<\/li>\n<li>Liaise with suppliers and clients on quality related issues.<\/li>\n<li>Perform an active role in further development and continuous improvement of the QMS.<\/li>\n<li>Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances &amp; customer complaints.<\/li>\n<li>Perform CAPA reports.<\/li>\n<li>Support clients in product submission to applicable regulatory authorities.<\/li>\n<li>Support Quality Department in implementing and maintaining QMS.<\/li>\n<li>Conduct internal audits and compilation of associated documentation.<\/li>\n<li>Support and assist in the preparation for customer and surveillance audits.<\/li>\n<li>Updates job knowledge by participating in educational opportunities.<\/li>\n<li>Other such duties as may be assigned from time to time by their manager.<\/li>\n<\/ul>\n<p><strong>Minimum requirements related to the&nbsp;position:<\/strong><\/p>\n<ul>\n<li>Minimum Degree in a Science or Engineering discipline.<\/li>\n<li>3-5 Years&rsquo; experience working in a medical device environment.<\/li>\n<li>Strong knowledge of ISO 13485, FDA regulations 21CFR 820.<\/li>\n<li>Strong knowledge of MDR &amp; FDA product submission requirement.<\/li>\n<li>Internal\/external auditing experience would be an advantage.<\/li>\n<li>Validation experience including Sterilization, process and packaging validations would be beneficial.<\/li>\n<li>Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.<\/li>\n<li>Strong understanding of the general principles of ISO 14971.<\/li>\n<li>Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required.<\/li>\n<li>Demonstrate detailed working knowledge of the medical device industry.<\/li>\n<li>Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers.<\/li>\n<li>Self-motivated, flexible with a desire to learn new tasks.<\/li>\n<li>Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives.<\/li>\n<li>Capacity to maintain the highest level of confidentiality internally and externally.<\/li>\n<li>Excellent MS Office experience (Word, Excel, PowerPoint etc.).<\/li>\n<li>High level of teamwork and engagement.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>For more information about this position or other opportunities, contact Tracey Hayden &nbsp;at Oradeo Recruitment confidentially on +353 087 1005229 or apply in confidence.<\/strong><\/p>\n<p><strong>About Oradeo<\/strong>&nbsp;&#8211; Oradeo Recruitment are specialists in the life sciences, pharmaceutical, construction &amp; engineering sector. We are a leading service provider in Ireland, UK and Europe for professional recruitment services and the provision of managed labour in Construction &amp; Civil Engineering, Data centres, Mechanical &amp; Electrical, Life Sciences and Renewable Energies sectors<\/p>\n<p>&nbsp;<\/p>\n<div class=\"pdfprnt-buttons pdfprnt-buttons-job_listing pdfprnt-bottom-right\"><a href=\"https:\/\/oradeo.com\/wp-json\/wp\/v2\/job-listings\/38893?print=pdf\" class=\"pdfprnt-button pdfprnt-button-pdf\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/oradeo.com\/wp-content\/plugins\/pdf-print\/images\/pdf.png\" alt=\"image_pdf\" title=\"View PDF\" \/><span class=\"pdfprnt-button-title pdfprnt-button-pdf-title\">Save PDF<\/span><\/a><a href=\"https:\/\/oradeo.com\/wp-json\/wp\/v2\/job-listings\/38893?print=print\" class=\"pdfprnt-button pdfprnt-button-print\" target=\"_blank\"><img decoding=\"async\" src=\"https:\/\/oradeo.com\/wp-content\/plugins\/pdf-print\/images\/print.png\" alt=\"image_print\" title=\"Print Content\" \/><span class=\"pdfprnt-button-title pdfprnt-button-print-title\">Print<\/span><\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>Quality Engineer Leading Medical Device Company in the Sligo Excellent career progression opportunities along with a generous package. Oradeo Recruitment&nbsp;is presently seeking interest for a&nbsp;Quality Engineer in our clients Division&nbsp;located&#8230;<\/p>\n","protected":false},"author":19,"featured_media":35382,"template":"","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_promoted":"","_job_location":"SLIGO","_application":"recruitment@oradeo.com","_company_name":"","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[3935],"job-types":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Quality Engineer | Oradeo<\/title>\n<meta name=\"description\" content=\"Oradeo Recruitment is presently seeking interest for the 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