Global Quality & Validation Lead - Medical Devices/IVDs

Greiner AG; Kremsmünster; On-site; EUR 55,000 - 67,000; Full time

Job summary

NEVEON Executive Committee is seeking a Global Quality Engineering & Validation Lead for Medical Devices/IVDs in Austria. You will harmonize validation strategies across manufacturing processes, sterilization, and methods, and drive compliant, efficient process transfers between international production sites.

Ideal candidates have 5+ years in regulated medical devices environments, strong QA knowledge, and fluency in English with good German.

Qualifications

• Degree in Engineering, Life Sciences, Biotechnology or related discipline
• 5+ years of experience in Medical Devices, IVD or other regulated industries
• Strong knowledge of Quality Engineering principles
• Hands-on experience in process/sterilization/method validation and technology transfer
• Experience working within FDA and ISO 13485 regulated environments
• Strong stakeholder management and communication skills
• Fluent English and very good German skills
• Experience with radiation or sterilization validation preferred
• Experience in international manufacturing networks preferred
• Knowledge of MDR and/or IVDR preferred

Responsibilities

• Lead global validation strategies for manufacturing processes
• Drive process transfer between international sites
• Assess the quality and regulatory impact of process changes
• Provide expert guidance on Quality Engineering and validation requirements within FDA and ISO-regulated environments
• Review and approve key global quality documents including validation and transfer master plans
• Partner with Operations, Manufacturing, R&D, Engineering, Quality and Regulatory Affairs teams worldwide
• Support the implementation of risk-based and state-of-the-arts validation approaches across the organization
• Serve as a global subject matter expert for validation

Skills

Quality engineering

Process validation

Sterilization

Technology transfer

FDA compliance

Stakeholder management

English/German

Education

Engineering degree

Life sciences degree

Biotechnology degree

Job description

NEVEON Executive Committee is seeking a Global Quality Engineering & Validation Lead for Medical Devices/IVDs in Austria. You will harmonize validation strategies across manufacturing processes, sterilization, and methods, and drive compliant, efficient process transfers between international production sites.

Ideal candidates have 5+ years in regulated medical devices environments, strong QA knowledge, and fluency in English with good German.