Senior Product Quality Engineer (f/m/d)

ApplyMint; Forchheim; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Siemens Healthineers is seeking a Senior Product Quality Engineer (f/m/d) for X-ray Products to advance product quality and patient safety across the development lifecycle.

You will plan and execute FMEAs, CAPA and APQP initiatives, drive reliability programs, and lead cross-functional teams with R&D, IT, Product Management, and Regulatory Affairs to sustain a culture of quality worldwide.

Qualifikationen

• Degree in natural sciences, engineering, or comparable field.
• In-depth knowledge of medical device product development, quality engineering methods, and reliability management.
• Certifications (e.g., CQE, CQA, Six Sigma) and strong quality methods (FMEA, 8D, RCA, APQP).
• Understanding of international post-market surveillance (EU, USA, Japan, China, Australia).
• Experience in a regulated environment, preferably medical technology or healthcare, with knowledge of MDSP, ISO 13485, FDA.

Aufgaben

• Plan, coordinate, and execute FMEAs, root cause analyses, and Lean Six Sigma initiatives to improve quality.
• Ensure field actions and CAPA comply with global regulatory requirements with statistical validation of effectiveness.
• Drive reliability management and contribute to long-term product reliability.
• Lead cross-functional task forces and coordinate stakeholders across internal and external teams.
• Collaborate with R&D, IT, Product Management, and Regulatory Affairs to foster a culture of quality.

Kenntnisse

German language fluency

English language proficiency

Ausbildung

Degree in natural sciences or engineering

Tools

FMEA

8D

APQP

CAPA

Jobbeschreibung

Senior Product Quality Engineer (f/m/d)

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Then come and join our global team as Senior Product Quality Engineer (f/m/d) for X-ray Products to support the development of innovative, high-quality products in the X-ray field while ensuring their impeccable quality, thereby making a direct contribution to patient safety and customer satisfaction worldwide.

Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.

Even more flexibility? Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries.

Your tasks and responsibilities:

• You are responsible for the planning, coordination, and execution of FMEAs, root cause analyses, and other Lean Six Sigma and APQP initiatives to sustainably improve product quality and serviceability.
• You ensure that field actions and CAPA comply with global regulatory requirements and approve them, providing well-founded statistical expertise to demonstrate their effectiveness.
• You drive the reliability management process and make a key contribution to long-term product reliability.
• You lead cross-functional task forces, coordinate internal and external stakeholders, and track measures through implementation.
• You work closely with interfaces such as R&D, IT, Product Management, and Regulatory Affairs, fostering a company-wide culture of quality.

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services

Your qualifications and experience:

• You hold a degree in natural sciences, engineering, or a comparable field, along with many years of professional experience in product or process improvement, ideally in a medical technology environment.
• You have in-depth knowledge of medical device product development processes, quality engineering methods, and reliability management.
• You possess professional certifications (e.g., CQE, CQA, Six Sigma Green-/Black Belt) and strong expertise in common quality methods (e.g., FMEA, 8D, root cause analysis, APQP).
• You have a solid understanding of international post-market surveillance requirements (EU, USA, Japan, China, Australia), particularly in reportable recalls.
• You bring experience from a regulated environment, preferably in medical technology or healthcare, and are confident in handling relevant standards and regulations (MDSP, ISO 13485, FDA).

Your attributes and skills:

• You consistently think about quality from the customer’s perspective and help ensure that our products continue to evolve reliably, even in dynamic environments.
• You communicate fluent in German and English and enjoy working with international colleagues.
• Clear and open communication is one of your strengths to drive topics and engage people across cross-functional teams.
• You take ownership, actively drive the consistent implementation of our high standards, and, together with internal and external stakeholders, foster a culture in which quality is an integral part of all decisions and processes.
• You have a strong digital affinity and have already designed AI agents (e.g., Copilot, Claude) to automate routine tasks and make processes more efficient.
• You are flexible, efficient and strategic in your thinking, helping to shape the future of quality management step by step.

Our global team:

Siemens Healthineers is a leading global medical technology company. 74,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture:

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. Check our Careers Site at https://www.siemens-healthineers.com/de/careers

As an equal opportunity employer, we welcome applications from individuals with disabilities. #myabilityshs

Siemens Healthineers Germany was awarded the Great Place to Work certificate.