Quality Engineer

Description

The quality engineer supports quality work for new product development and introduction, and for ongoing manufacturing. You will own and complete projects that improve the products and processes used at the company.

Your main role is EMEA DRI for the SAP S4 HANA project. You will give guidance, set technical requirements and model the many quality processes that connect SAP S4 and SAP ME.

The company is a pioneer and market leader in robotic-assisted surgery. For more than 25 years it has worked with hospitals and care teams worldwide.

Responsibilities

• Lead the design, build and rollout of SAP-enabled business processes, focused on Quality Operations and Quality Engineering.
• Work with cross-functional teams to define business requirements and make sure SAP solutions meet business goals.
• Oversee testing and validation of SAP functions to confirm system integrity and compliance.
• Drive sustainment and continuous improvement work that raises system performance and business results.
• Coordinate with IT, process owners, analysts and stakeholders to improve SAP adoption and use.
• Act as the main link between business units, IT and external vendors so integration and deployment run smoothly.
• Track industry trends and best practices to bring new ideas and operational excellence into SAP processes.
• Make sure work meets the regulatory and compliance standards for medical devices.
• Contribute to the Quality Center of Excellence, advancing best practices, standardization and continuous improvement in quality processes.
• Lead the development, implementation and management of SAP solutions for quality functions, in line with industry standards and regulations.

Requirements

• A bachelor's degree with at least 5 years of relevant experience, or a master's degree with at least 3 years of relevant experience.
• Experience with SAP business process management in a manufacturing setting.
• Strong skills in SAP modules ME, MM, PP and QM.
• A proven record of leading teams and cross-functional projects.
• Experience leading quality functions, covering process design, implementation and compliance in a regulated industry. Medical device experience is preferred.
• Strong communication and stakeholder management skills.
• Excellent problem-solving, analytical and decision-making skills.
• Experience running small projects independently.
• Understanding of root cause investigation and problem-solving methods.
• Working knowledge of ISO 13485 and EU MDR requirements.
• Deep understanding of Device History Records (DHR/eDHR) and how they relate to the Device Master Record (DMR).
• Experience with Lean Manufacturing or Six Sigma methods.
• Ability to travel within the country and internationally, up to 25% as needed.

Conditions

The company asks for equal treatment regardless of gender, ethnic or social background, religion, disability, age or sexual identity.

US export control notice: some positions may be subject to US export controls for candidates who are citizens of countries currently under embargo or sanctions. Information you provide in the application may be used to decide whether the company must obtain a US government export license, which can take up to six months, or put in place a Technology Control Plan (TCP), which typically adds about 2 weeks to hiring.

For roles subject to export controls, any offer is conditional on an approved export license and/or a fully executed TCP before the planned start date. The start date may move if approval would otherwise unreasonably delay hiring.

The role may be filled at a different job level than listed, depending on business needs and the selected candidate's experience. Pay follows the job level and the candidate's qualifications, within legal requirements.