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 3,100 employees around the world.
QA_22512
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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 xjliken approach
Good communication skills in written and spoken English. German skills are a plus
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 37,361.66.