Senior Expert Global Design Assurance Engineering (all genders)

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

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

• 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-arts 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.