Process Validation Engineer - Additive Manufacturing

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    "description": "<p> </p>\n<p>Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients ’lives?</p>\n<p>Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes?</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">                                        If yes, come to join our Process Validation team </span></p>\n<p><span style=\"font-weight: bold\">                                                       (Additive Manufacturing)</span></p>\n<p>                                Together we can shape the future of the healthcare.</p>\n<p> </p>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">As Process Validation Engineer </span>you will participate to the qualification-validation strategy for the processes and activities for which you are responsible (internally and externally).</p>\n<p>You will work in close collaboration with R&amp;D, Operations and RA departments and with sub-contractors to qualify their processes.</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">Your main responsibilities will be:</span></p>\n<p><br><br></p>\n<ul style=\"list-style-type: circle;\">\n<li><span>As </span>Subject Matter Expert (SME) in Additive Manufacturing for Medical Devices</li>\n</ul>\n<p><span> </span></p>\n<ul>\n<li><span>Managing and monitoring </span>Additive Manufacturing<span> qualification activities, </span>including environmental monitoring and requalification. <br></li>\n<li><span>Coordinating/executing validation activities (IQ/OQ/PQ) for equipment, utilities, and cleanroom systems.</span></li>\n<li><span>Leading investigations, root cause analysis, CAPA, and non-conformity resolution linked with clean room environment</span></li>\n<li><span>Ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745, and internal quality systems.</span></li>\n<li><span>Analysing quality metrics and identifying opportunities for continuous improvement.</span></li>\n<li><span>Creating, Reviewing and approving quality documentation, SOPs, protocols, and reports.</span></li>\n<li><span>Interacting with auditors </span></li>\n<li><span>Collaborating with Production, Engineering, Regulatory Affairs, and suppliers </span></li>\n</ul>\n<p><span> </span></p>\n<ul style=\"list-style-type: circle;\">\n<li>As a key contributor to the quality roadmap across the product development lifecycle:</li>\n</ul>\n<p> </p>\n<ul>\n<li>Participating to DHF completeness</li>\n<li>Defining, Planning , executing and reviewing all validation/verification activities </li>\n<li>Managing all changes including impact assessment </li>\n</ul>\n<p><br><br></p>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Your profile:</span></p>\n<p><br><br></p>\n<ul>\n<li>Proven experience in Validation and Qualification processes, with demonstrated use of <span style=\"font-weight: bold\">ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR 2017/745</span></li>\n<li>Minimum of 3 years’ experience in <span style=\"font-weight: bold\">additive manufacturing</span> using metallic materials</li>\n<li>Experience in orthopaedics and/or spinal medical device development is a strong advantage</li>\n<li>Higher education degree in Engineering, preferably Mechanical Engineering</li>\n<li>Ability to work effectively <span style=\"font-weight: bold\">in English</span>; native or near-native level of <span style=\"font-weight: bold\">French</span></li>\n<li>Strong communication skills, with the ability to clearly convey technical information to diverse audiences and explain complex regulatory requirements in simple terms</li>\n<li>Excellent technical writing skills, including structured documentation such as protocols, reports, and audit-ready records</li>\n<li>Ability to manage multiple projects and validation activities under tight deadlines</li>\n<li>Ability to challenge decisions that may impact patient safety or regulatory compliance</li>\n<li>Strong problem-solving skills with a pragmatic and solution-oriented approach</li>\n<li>Valid driving licence</li>\n</ul>",
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