Senior Engineer, Quality

Work Flexibility: Onsite<p></p><p></p><p>12 month contract</p><p></p><p><b>What you will do:</b></p><p></p><h2>Position Summary</h2><p>Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives &amp; projects to enhance quality performance within the business. Ensure compliance to regulation and standards.</p><p></p><ul><li>Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:</li><li>Work closely with operations and the business functions to ensure quality performance of product and processes.</li><li>Oversight and approval of NC &amp; CAPA, activist and mentor in problem solving and root causing activities.</li><li>Lead and participate in the development and improvement of the manufacturing processes for existing and new products.</li><li>Analysis and review of concession requests.</li><li>Review and approval of change management activities.</li><li>Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.</li><li>Support execution and analysis of QATs.</li><li>Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.</li><li>Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.</li><li>Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.</li><li>Proficiency in statistical methods and application.</li><li>Participate and interface in internal &amp; external audits with regulatory representatives, providing effective narrative and description of topic of expertise.</li><li>Assist in the development, responsible for review &amp; approval of process and equipment <span>validation/qualification.</span></li><li>Support manufacturing transfers to other plants/facilities, leading quality activities.</li><li>Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.</li><li>Coach and mentor others in quality topics and activities.</li></ul><p></p><h2>What you will do:</h2><ul><li>Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline.</li></ul><p></p><p></p><ul><li><b><span>                                                    </span> <span>                                        </span></b></li></ul><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>