University Bridge Fund

WHO ARE WE?

LUMA Vision is a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion and focus, we apply our best-in-class engineering and design knowhow to create new hardware, software and data science technologies.

The position, based remotely in Galway and reporting to the Quality Manager. This role will encompass working directly with contract catheter manufacturer, based in Galway, to support the development, implementation, and continuous improvement of manufacturing operations. In addition, this role will also ensure the quality of products sourced from all suppliers, leading quality improvement initiatives and ensuring compliance with industry standards.

Your role will be

• Support root cause analysis (RCA) and failure mode analysis (FMEA) to identify production issues and implement corrective and preventive actions (CAPA)
• Work cross-functionally, and across organizations (with contract manufacturer) to support the production team in achieving process capability goals and ensuring compliance with internal and external quality standards.
• Establish and monitor key quality metrics (e.g., defect rates, yield, scrap rates) and collaborate with production teams to drive improvement
• Support Process Validation activities, at contract manufacturer
• Ensure compliance between Luma Vision QMS, and contract manufacturer QMS
• Lead the development and implementation of Supplier Quality Management programs to ensure the consistent supply of high-quality materials and components
• Collaborate with suppliers to resolve quality issues, manage corrective actions, and support preventive action implementation
• Support product transfer to contract manufacturer projects, as required
• Develop and maintain supplier quality agreements and work closely with the Procurement and Sourcing teams to select and evaluate suppliers
• Ensure the integration of Supplier Quality standards into the product lifecycle and communicate key quality expectations to suppliers
• Conduct Supplier and Internal Audits
• Support the Quality Manager in all quality issues in Luma Vision

What you offer

• Minimum of 7-10 years of experience, with a focus on Supplier Quality Management and Production Quality
• Lead Auditor Qualification, with Proven experience in leading supplier audits, managing supplier relationships, and overseeing production quality activities in a manufacturing environment
• Proven experience in process quality assurance, root cause analysis, statistical process control, and continuous improvement
• Demonstrated success in driving continuous improvement initiatives
• Ability to influence others and drive quality initiatives across departments, and organizations
• Strong project management skills and ability to lead multiple initiatives simultaneously
• Willingness to travel up to 25%

WHAT WE OFFER

• Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A learning environment where you can extend and build upon your skills and interests.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.

LUMA Vision is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation, or age.

Would you like to become part of our team? We would love to hear from you and look forward to receiving your CV and cover letter. Please apply for the position at jobs@lumavision.com