Senior Quality Engineer, Glasgow

Senior Quality Engineer

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Senior Quality Engineer page is loaded## Senior Quality Engineerremote type: Hybridlocations: NDE Gtime type: Full timeposted on: Posted Todayjob requisition id: R-24006Join 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.This Quality Engineering position at Glasgow is a senior-level role involved in developing, implementing, maintaining, and improving systems to ensure products and processes are designed and produced to meet or exceed customer requirements and expectations. The role also ensures proactive, consistent implementation and compliance to the Siemens Healthcare Diagnostics Quality System and external regulations including, but not limited to, the FDA Quality System Regulation (21 CFR Part 820), ISO 13485, MDSAP, and In-Vitro Diagnostics Directives.In the Glasgow location, the QE’s responsibilities include providing senior-level Quality Engineering support for Design Transfer, Design Changes, Change Control, Process Validation, Equipment Qualification, 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 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 quality notifications, root cause investigations, and post-market/post-manufacturing changes.* Participating in the change management process to ensure products, systems, and processes continue to meet 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 the 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.* 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 10 years of experience in the medical device, pharmaceutical or biotechnology industry.* 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 leadership and advisement to project teams to facilitate capturing the quality requirements related to Design Controls, Process and Computerized Systems Validation and Control, 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 73,000 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 .The annual base pay for this position is:Min $137,300 - Max $205,900Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.The Company offers the following benefits for this position, subject to applicable eligibility requirements: 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 Statement:** Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.**EEO is the Law:** Applicants and employees are protected under Federal law from discrimination.**Reasonable Accommodations:** Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form . If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.**California Privacy Notice:** California residents have the right to receive additional notices about their personal information. To learn more, click .**Export Control:** “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”**Data Privacy:** We care about your data privacy (https://www.siemens-healthineers.com/careers/recruitment-application-privacy-notice) and take compliance with GDPR as well as other data protection legislation seriously. For this reason, #J-18808-Ljbffr

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Location:: Glasgow
Job Type:: FullTime
Category:: Engineering

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