Senior Quality Assurance Professional

Senior Quality Assurance Professional

Senior Quality Professional

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 a Senior Supplier Quality Professional at our facility in Swords, Co. Dublin

Your tasks and responsibilities:

• As a key member of the team, you will be part of a highly innovative production and Quality network working to deliver high Quality product to serve the needs of laboratories of any size - today and tomorrow.
  
  
• Proven experience in QMS working 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 and leadership in these areas.
  
  
• Prominent in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, CAPA, 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.
  
  
• As a member of the site Quality team, you will focus on and be responsible for process design improvements and updating quality system procedures to achieve both fully compliant and lean processes.
  
  Your qualifications and experience:
  
  
• Using lean tools, own and lead quality projects that deliver quality, cost, and process improvements.
  
  
• Assess manufacturing's capability to meet quality requirements based on data analysis and internal audit. As a follow-on activity create concise reports that enable project teams to implement improvements and corrective actions.
  
  
• Experienced in the use of statistical analysis to support technical report writing to meet Quality Systems and regulatory standards of excellence.
  
  
• Worked within Quality in a manufacturing environment for complex electro-mechanical equipment.
  
  
• Minimum of a Bachelor’s degree in a relevant technical discipline (ideally Quality, Engineering or Science). 8 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.
  
  Your attributes and skills:
  
  
• High paced individual who is eager and passionate in developing and delivering quality solutions in close collaboration with suppliers & key stakeholders.
  
  
• Strong leadership 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