Senior 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.

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

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.

The Annual Base Pay For This Position Is Min $137,300 - Max $205,900

Factors which may affect starting pay within this range may include geography / market, skills, education, experience, and other qualifications of the successful candidate.

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.

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