Key Responsibilities:
Perform routine testing services using established procedures/protocols (e.g. sterility bioburden aseptic filtration environmental collection and testing in process solutions etc)
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
Update operating procedures and ensure that specifications are in compliance with GMP Environment and Safety regulations
May maintain basic equipment by following procedures and executing PM (preventative maintenance) per established schedule
Education and Experience:
Other: NITEC or equivalent in related science field 1 year previous experience working in a laboratory environment required or
Other: Higher NITEC or equivalent in related science field required or
Associates Degree or equivalent Diploma in related science field preferred or Bachelors Degree in related science field preferred
Additional Skills:
Good written and verbal communication interpersonal and relationship building skills
Good computer skills including usage of MS Office
Moderate knowledge of laboratory processes
Moderate knowledge in QSR (Quality System Regulation) FDA (Food and Drug Administration) and ISO (International Organization for Standardization) regulations
Moderate knowledge in mathematics e.g. decimals and percentage
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
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 and with close supervision
Adhere to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Required Experience:
IC
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more