Quality Engineer

SmartRecruiters, Inc.; Freiburg im Breisgau; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Intuitive, a market leader in robotic-assisted surgery, seeks a Quality Engineer to drive SAP-enabled quality processes for new product development and manufacturing. This role will focus on S4 HANA as the EMEA DRI, defining requirements and modeling quality workflows across SAP modules.

You will collaborate with IT, process owners, and vendors to ensure SAP solutions meet business goals, with a strong emphasis on regulatory compliance in the medical device sector and continuous improvement.

Qualifikationen

• Bachelor's degree in a relevant field.
• Master's degree in a related field preferred.

Aufgaben

• Lead design, development, and implementation of SAP-enabled processes for Quality Operations.
• Collaborate with cross-functional teams to define requirements and align SAP with business objectives.
• Oversee testing and validation of SAP functionalities to ensure compliance.
• Drive sustainment and continuous improvement initiatives to enhance system performance.
• Interface with IT, process owners, analysts, and stakeholders to optimize SAP adoption and utilization.
• Liaise between business units, IT, and external vendors to ensure seamless integration.
• Monitor industry trends and best practices to drive innovation in SAP quality processes.
• Ensure adherence to regulatory standards specific to the medical device industry.
• Contribute to the Quality Center of Excellence to drive standardization and improvements.
• Provide leadership in SAP quality solutions, ensuring regulatory compliance.

Kenntnisse

Leadership

Stakeholder management

Communication

Problem-solving

Project management

Quality systems

Travel readiness

Ausbildung

Bachelor's degree in a related field

Master's degree in related field

Tools

SAP - ME/PP/QM/MM

DHR/eDHR knowledge

Jobbeschreibung

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Professional 3 (9)

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere-we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture-our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real-world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Primary Function of Position:

The Quality Engineer will be responsible for quality aspects for supporting new product development/introduction, sustaining manufacturing and owning/completing projects to improve the performance of the products and processes we utilize at Intuitive. Main responsibility will be to perform as the EMEA DRI for S4 HANA project, providing guidance, determining technical requirements and modeling for the multiple quality processes related with SAP S4 and SAP ME.

Roles and Responsibilities:

• Lead the design, development, and implementation of SAP-enabled business processes, with a focus on Quality Operations and Quality Engineering.
• Collaborate with cross-functional teams to define business requirements and ensure SAP solutions align with business objectives.
• Oversee the testing and validation of SAP functionalities to ensure system integrity and compliance.
• Drive sustainment and continuous improvement initiatives to enhance system performance and business outcomes.
• Interface with a team of IT, process owners, analysts, and stakeholders to optimize SAP adoption and utilization.
• Serve as a key liaison between business units, IT, and external vendors to ensure seamless integration and deployment.
• Monitor industry trends and best practices to drive innovation and operational excellence within SAP processes.
• Ensure adherence to regulatory and compliance standards specific to the medical device industry.
• Contribute to the Quality Center of Excellence to drive best practices, standardization, and continuous improvement in quality-related processes.
• Provide leadership in developing, implementing, and managing SAP solutions for quality functions, ensuring compliance with industry standards and regulations.

Required Knowledge, Skills, and Experience:

• Bachelor's degree with a minimum of 5 years of relevant experience, or a Master's degree with a minimum of 3 years of relevant experience.
• Experience in SAP business process management within a manufacturing environment.
• Strong expertise in SAP modules (ME, MM, PP, QM).
• Proven leadership experience managing teams and cross-functional projects.
• Experience leading quality functions, including process design, implementation, and compliance in a regulated industry (medical devices preferred).
• Strong communication and stakeholder management skills.
• Excellent problem-solving, analytical, and decision-making skills.
• Experience independently managing small projects.
• Understanding of root cause investigation and problem-solving processes.
  Deep understanding of Device History Records (DHR/eDHR) and their relationship to the Device Master Record (DMR).
• Experience with Lean Manufacturing or Six Sigma methodologies.
• Ability to travel domestically and internationally up to 25% as needed.