Quality Engineer

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.

In the Glasgow location, the QE’s responsibilities include providing Quality Engineering support for Commercial Products, post-market/post-manufacturing changes, Process Validation, Equipment Qualification, Design Transfer, Design Changes, and Risk Assessment, Risk Management, & Statistical Process Control.  This role reports to the Sr. Director of Quality.

Key functions of the QE role include:

• 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.

• Providing quality engineering expertise in design control, process validation, statistical analysis, risk assessment, and risk management within a Class II and Class III In-Vitro Diagnostics 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.

 

Required Knowledge/Skills, Education, and Experience:

• 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 ISO14971.

• 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.

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page