Medical Device Tester
4 days ago
We are seeking a skilled Medical Device Tester to join our team at Edwards Lifesciences.
About the Role:
The successful candidate will provide testing services in a laboratory environment, ensuring the highest standards of integrity and safety. This role involves routine testing services using established procedures/protocols, collecting environmental lab samples, performing data entry, and reviewing job functions for compliance with work instructions and SOPs.
Key Responsibilities:
- Perform routine testing services using established procedures/protocols (e.g., sterility, bioburden, aseptic filtration, environmental collection and testing, receive, inspect, in-process solutions, etc.)
- Collect environmental lab samples from multiple cleanrooms
- Perform data entry of routine testing
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
- Assist in testing validation/revalidation activities for critical systems and equipment under close supervision
- Maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
- Update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
- Other incidental duties
Education and Experience:
Bachelor's Degree or equivalent in a related science field, 1 year of previous experience working in a laboratory environment required.
Additional Skills:
- Good written and verbal communication, interpersonal, and relationship-building skills
- Able to read, comprehend, write and speak English
- Good computer skills, including usage of MS Office
- Moderate knowledge of laboratory processes
- Knowledge of QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
- Strict attention to detail
- Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
- Must be able to work in a team environment
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