Job Description
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 2,800 employees around the world.
QA_22501
Computerized System Validation Associate (m/f/d)
Quality Assurance
Innsbruck, Austria
Professionals Full-Time 38.5 h Limited 31-Aug-2026
- Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure successful documentation and validation of systems according to internal procedures
- Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and other relevant guidelines
- Maintain validation documentation, review the risk assessments for new and existing computerized systems
- Conduct periodic reviews and trigger the re-validation of systems as required
- Stay current with industry trends, regulatory changes, and best practices in computerized system validation
- Knowledge of regulatory requirements and guidelines, or certification (FDA 21 CFR Part 11, GxP, etc.) would be a benefit
- Previous work experience in Computerized System Validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) would be an advantage
- 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
- 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).