Senior Quality Engineer - Fixed Term Contract

Work Flexibility: Hybrid<p></p><p></p><p></p><p><b><span>Purpose of Job</span></b></p><p><span>Provide quality leadership 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. Mentor and provide technical direction across multiple areas of expertise. </span><span>Ensure compliance to regulation and standards.</span></p><p></p><p><b>Key Responsibilities</b></p><p></p><p>Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, 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>Mentors, provides oversight and approval of NC &amp; CAPA, activist and high level expert in problem solving and root causing activities.</li><li>Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.</li><li>Oversight and leads investigations during concession management.</li><li>Review and approval of change management activities, challenges change effectiveness and drives strong review.</li><li>Interpret KPI trends, take action as necessary, driving a continuous improvement process.</li><li>Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.</li><li>Subject matter expert 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 provides technical direction in optimization of inspection methods and sampling.</li><li>Participate in and may lead internal &amp; external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.</li><li>Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.</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></ul><p></p><p><b>Who we are looking for </b></p><p></p><ul><li>Bachelor of Science, Engineering or related subject and <b>4 years</b> of work experience in a quality discipline.</li><li>Proficient in understanding of Med Device manufacturing processes preferred.</li><li>Proficient in ISO 13485, GDP, GMP.</li><li>Must be willing to work as part of a multi-site team, with some travel required.</li><li>High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&amp;Rs.</li><li>Excellent <b>English </b>and <b>Polish </b>(both oral and written)</li><li>Experience in project transfer and validation processes</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>