Job Description
Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as **ROLE**, at our facility in Swords, Dublin. Your tasks and responsibilities: Contributing and leading in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation. Has demonstrated strong competencies in these areas. Active in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, continuous improvement changes, and post-production (proactive surveillance). This will require a systems mindset incorporating a cross technology understanding, in addition to a core appreciation of risk and regulatory requirements. Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control. Focus on and be responsible for process quality design improvements and updating quality system procedures to achieve both fully compliant and lean processes. To find out more about the specific business, have a look at Siemens Healthcare Diagnostics Manufacturing Limited - Swords ((url removed)) Your qualifications and experience: 5 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management incl. writing and / or reviewing Quality related procedures, plans, and reports. Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience. Experience in being a part of teams and projects with strong communications written and verbal. Ability to work in technically complex multi discipline areas across the whole supply chain, including the supplier environment. Your attributes and skills: High paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with key stakeholders. Strong skills and ability to influence cross-functional teams to drive workscope to completion. Self-starter, bias for action with ability to follow assignment through to completion. Good organization skills. Cross technology and cross discipline collaboration skills. Aptitude for systems level thinking, including development of standard operating procedures. Ability to write structured, concise, unambiguous technical English with high attention to detail. Core understanding of statistical analysis and design of experiment experience. Familiar with statistical software packages e.g., Minitab. Computer literacy (including MS Word/ Excel/ PowerPoint/ MS Project) and Interface to Product Lifecycle tools such as SAP, Teamcenter or other. Presentation skills whereby complex messages can be presented to an auditor/ inspector in a succinct manner i.e., ability to present and to sell convincingly. Understanding of Immunology, Biochemistry & Hematology diagnostic technologies would be an advantage. Our global team: We are a team of more than 70,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at Jobs at Siemens Healthineers ((url removed)) As an equal opportunity employer, we welcome applications from individuals with disabilities. We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. #siemens