Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
How you will make an impact:
• Conduct studies to establish sterilization levels and system validation for sterility, antimicrobial and environmental controls including evaluating and updating microbial protocols
• Identify basic testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards
• Create and develop validation plans for laboratory equipment and methods
• Collect samples for studies
• Develop protocols, reports, and methods in collaboration with inter-departmental teams
• Investigate and perform lab corrective and preventative actions (CAPA) testing
• Set parameters of complex laboratory machines applying microbiology knowledge and concepts to perform receiving inspection, raw materials, environmental control testing, in-process solutions, and final product release testing
• Participate in process improvement projects (e.g. BEST, Lean) and propose recommendations for manager approval
• Interpret data, perform trend analysis, and define qualification strategies for new or modified devices and/or processes
• May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
• Other incidental duties assigned by Leadership
What you'll need (Required):
• Bachelor's Degree in In Microbiology, 1 year experience in a microbiology environment preferred
What else we look for (Preferred):
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving skills
• Good knowledge and understanding of Edwards policies and procedures relevant to microbiology
• Good knowledge and understanding of microbiology principles, theories and concepts
• Good understanding of at least one of the following areas: sterilization process, final release testing, and environmental controls
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good written and verbal communications skills
• Good problem-solving skills
• Strict attention to detail
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Ability to interact professionally with all organizational levels
• 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
• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
Edwards Lifesciences Singapore, Singapore, SGP Office
35 Changi North Crescent, Singapore, Singapore, 499641
