Provide testing services in a laboratory environment
**Key Responsibilities**:
- Perform routine and non-routine testing services by using established procedures/protocols (e.g., manufacturing investigations, FETS, glut, TLS, sterility, receive, inspect, in process solutions, etc.)
- Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
- Perform investigations on CAPA forms e.g., NCRs,, OOT, OOS, for tests or processes nonconformance and identify root cause and propose corrective actions for manager approval
- Prepare data summaries, reports, and protocols using existing templates as a model as well as review and approve basic laboratory data and may propose recommendation on template changes
- Assist with routine manufacturing equipment validation by coordinating testing schedules and performing data analysis
- Create and develop validation plans for laboratory equipment and methods
- Lead laboratory investigations and propose recommendations and solutions for manager approval
- Propose and update operating procedures and ensure that specifications are in compliance with GMP, Environment and Safety regulations
- May train, coach, and guide lower level technicians on new procedures, assess work techniques and provide feedback on procedures
- Other incidental duties
**Education and Experience**:
Associate's Degree or equivalent 5 years years experience of previous experience working in a laboratory Required or
Bachelor's Degree or Equivalent in Chemistry and/or Microbiology Preferred
**Additional Skills**:
- Able to read, comprehend, write and speak English
- Excellent computer skills, including usage of MS Office; Analytical Equipment System (e.g., ChemStation, Empower) preferred
- Full knowledge of laboratory processes
- Full knowledge in QSR (Quality System Regulation), FDA (Food and Drug Administration), and ISO (International Organization for Standardization) regulations
- Full knowledge in mathematics, e.g., decimals and percentages
- Ability to write technical documents
- Strong knowledge with ISO sterilization documents if applicable
- 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 an inter-departmental team environment, as well as with colleagues from other departments
- Ability to provide feedback in a professional, direct, and tactful manner
- Ability to represent the organization to outside contacts, i.e., vendors
- 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
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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