Job
- Level
- Experienced
- Job Field
- Test/QA
- Employment Type
- Full Time
- Contract Type
- Temporary employment
- Salary
- from 37.361 € Gross/Year
- Location
- Innsbruck
- Working Model
- Onsite
Your role in the team
- 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.
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Our expectations of you
Qualifications
- Knowledge of regulatory requirements and guidelines, or certification (FDA 21 CFR Part 11, GxP, etc.) would be a benefit.
- MS Office proficiency and good general computer skills.
- Good organizational skills, be self-motivated and have a detail-oriented approach.
- Good communication skills in written and spoken English. German skills are a plus.
Experience
- Previous work experience in Computerized System Validation within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) would be an advantage.
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Benefits
Work-Life-Integration
More net
Health, Fitness & Fun
Job Locations
Location Innsbruck
Tirol
Austria
Topics that you deal with on the job
This is your employer
MED-EL Medical Electronics
Innsbruck
At MED-EL, we are a leading manufacturer of innovative products and technologies for people with all types of hearing loss. Our unique range of high-tech implantable hearing systems allows thousands of users to participate in the world of sound once again, overcoming hearing loss as a communication barrier.
Description
- Company Size
- 250+ Employees
- Language
- English
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Healthcare, Social Sector, Industry, Production
Dev Reviews
by devworkplaces.com
Total
(2 Reviews)4.0
Culture
4.2Career Growth
4.2Workingconditions
4.0Engineering
3.6
Computerized System Validation Associate
- Salary
- from 37.361 € Gross/Year
- Location
- Innsbruck
- Working Model
- Onsite
