Quality Engineer

Quality Engineer Siemens Healthineers Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Location Glasgow, UK Responsibilities Providing quality engineering expertise in commercial product support and troubleshooting, design control, process validation, statistical analysis, risk assessment, and risk management within a Class II and Class III IVD reagent manufacturing facility. Collaborating as part of cross?functional teams alongside business, production, technical, and engineering disciplines. Supporting assigned product and process topics, including advising teams and internal partners on requirements and deliverables for post?market & post?manufacturing changes, quality notifications, nonconformances, corrective actions and preventative actions (CAPA), and root cause investigations. Participating in the change management process to ensure products, systems, and processes continue to meet internal and external customer requirements. Providing independent quality engineering oversight and review, as assigned, of project deliverables throughout the product lifecycle. Proactively working cross functionally with internal partners as part of continuous improvements for products and processes. Serving as a quality engineering representative on the team responsible for technical transfer from design to manufacturing. Trending and analysis of process and product?related data related to quality systems, product/process control, and for identification of product/process improvement, including use of digital tools to improve trending efficiencies. Incorporating the use of digital tools as part of day to day and project?related activities. Lead or participate in internal and external audits as needed. Qualifications BS in Life Science or Engineering discipline with a minimum of 5?8 years of Quality Engineering experience in the medical device, pharmaceutical or biotechnology industry, preferably with experience in supporting In?Vitro Diagnostics. Strong knowledge of FDA Quality System Regulation (QSR) with an emphasis on Process Validation and Design Controls; ISO 13485 and MDSAP; and ISO 14971. Proven experience providing quality engineering support to project teams to facilitate capturing the quality requirements related to Commercial Product Support, Design Controls, Process Validation, Computerized Systems Validation, Equipment Qualification, Analytical Test Method Characterization & Validation, Statistical Process Control, and Risk Management. Use of digitalization tools and AI as part of continuous improvement and efficiency efforts is a plus. Base Pay Range Min $117,770 Max $176,650 (Geography and market may affect starting pay). Benefits Medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long?term and short?term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time. Equal Employment Opportunity Siemens Healthineers is an Equal Opportunity and without regard to Reasonable Accommodations Siemens Healthineers is committed to equal employment opportunity. To learn more, click here. If you require a reasonable accommodation please fill out the accommodations form here. Export Control A successful candidate must be able to work with controlled technology in accordance with US export control law. Data Privacy 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 Scam Warning Please beware of potentially fraudulent job postings or suspicious recruiting activity #J-18808-Ljbffr