Computerized System Validation Associate (m/f/d)

MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 3,000 employees around the world.

QA_22512
Computerized System Validation Associate (m/f/d)
Quality Assurance
Innsbruck, Austria
Professionals | Full-Time 38.5h | Limited 12 months

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications
• Conduct periodic reviews and improve existing documentation of systems
• Stay up to date with industry trends, regulatory changes, and best practices in computerized system validation

• Prior experience in Computerized System Validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) or basic knowledge of regulatory requirements and guidelines, or certification (FDA 21 CFR Part 11, GxP, etc.) would be beneficial
• MS Office proficiency and good general computer skills
• Good organizational skills, be self-motivated and have a detail-orientated approach
• Good communication skills in written and spoken English. German skills are a plus