Global Quality Engineering & Validation Lead - Medical Devices / IVDs (all genders)

Your challenge

• Lead and harmonize global validation strategies for manufacturing processes, sterilization and methods
• Drive compliant and efficient process transfer activities between international production 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-art validation approaches across the organization
• Serve as a global subject matter expert for validation

Your Profile

• 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

Our Offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 60.977,70 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.

If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!