Senior Supplier Quality Engineer
3 weeks ago
Senior Supplier Quality Engineer
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.
Then come and join our global team as a Senior Supplier Quality Engineer 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.
- Act as a key liaison and knowledge transfer champion among Supplier Quality, Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
- Assess suppliers' capability to meet quality requirements based on data analysis and supplier audit. Create concise reports that enable project teams to implement improvements and corrective actions.
- Use statistical analysis to support suppliers and drive regulatory standards of excellence. Develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
- Work with suppliers in a wide range of Quality relevant areas such as First Articles, general Quality and Regulatory requirements. Work with suppliers on corrective & Preventative Actions, Root Cause Investigations, conduct Supplier Performance Reviews and reporting of Key Supplier Quality metrics.
Your qualifications and experience:
- Proven experience in Medical Devices QMS to develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment (diagnostic instrumentation).
- Lead projects to manage suppliers to deliver quality product to internal customers, through product & process investigations & evaluations. Identify and drive process improvements with suppliers.
- Responsible for Supplier process improvements and updating quality system procedures to achieve both fully compliant and lean processes with suppliers.
- 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 culture:
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.
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.
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