Senior Quality Engineer

Work Flexibility: Hybrid<p></p><p></p><p><u><b>Senior Quality Engineer - temporary assignment </b></u></p><p>Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions with a focus on cost reduction initiatives. Advocate and lead the execution of inspection optimization activities, keeping a high quality performance within the business and for our customers. Ensure compliance to regulation and standards.</p><p></p><p>You will work within the quality operations team, under moderate supervision and mentoring, with a daily business responsibility for quality related activities (internal and supplier), including, but not limited to the following:</p><ul><li>Work closely with operations and the business functions to ensure quality performance of product and processes</li><li>Launch Inspection Optimization activities</li><li>Own, oversight and approval of NC &amp; CAPA, activist and mentor in problem solving and root causing activities</li><li>Disposition non-conforming product within MRB, issuing NC's as appropriate</li><li>Communicate &amp; collaborate with suppliers regarding non-conformances, escalating supplier corrective action requests as required. Lead the solving of supplier quality issues impacting daily operations</li><li>Lead and participate in the development and improvement of the manufacturing processes for existing products</li><li>Lead the deployment of cost reduction initiatives</li><li>Support and collaborate with EUMDR team for the management of non conformities</li><li>Participates and leads the creation and/or review of new or modified procedures</li><li>Initiate KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary</li><li>Support execution and analysis of manufacturing related complaints and product field actions (PFA)</li><li>Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation</li><li>Develop and provide input for risk management by identifying opportunities and weaknesses</li><li>Support the creation and maintenance of inspection methods and sampling</li><li>Proficiency in statistical methods and application</li><li>Assist in the development, responsible for review and approval of process and equipment <span>validation/qualification</span> and MSA of internal processes</li><li>Responsible for initiation, internal containment, communication and support of Commercial Holds for potential product escapes</li><li>Support execution and analysis of QATs</li><li>Support First Article Inspections</li></ul><p></p><p><b>What you need:</b></p><ul><li>Engineering studies with 2 or more years of experience in biomedical or regulated environment</li><li>Proven previous experience in industrial quality environment (production, engineering), experience in supplier management is a plus</li><li>Systems: experience in quality tools, NC/CAPA management as well as project management, Qualification/ Validation process knowledge</li><li>Good communication skills, capable of influencing without authority, good organizational skills, leadership, critical thinking, high responsiveness</li><li>Languages fluent in French &amp; English</li></ul><p></p><p></p><p></p><p></p>Travel Percentage: 10%<p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p>