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

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.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of characteristics such as gender, age, background, social status, sexual orientation, religion, or mental and physical abilities. We have set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.

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