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
• Compose protocols for sterilization or system validation/ sterility and antimicrobial controls; monitor and recommend controls for manufacturing environments, systems, and sterilization processes
• Identify more complex testing approaches to perform microbiological testing, investigations, isolation and identification using Edwards and outside guidance standards
• Develop protocols, reports, and methods in collaboration with inter-departmental teams
• Collect samples for studies
• Investigate and perform lab and manufacturing corrective and preventative actions (CAPA) testing
• May train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures
• 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
• Lead smaller 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
• Make recommendations and validate new laboratory equipment
• Other incidental duties assigned by Leadership
What you'll need (Required):
Bachelor's Degree in In Microbiology , 2 years experience in a microbiology environment Required or Master's Degree or equivalent in In Microbiology experience in a microbiology environment required
Experience with aseptic techniques for bioburden and sterility tests, microbiological inoculums, assays, pipettes, identification and characterization, testing of medical devices, manufacturing processes, systems, and facilities, qualification involving sterilization processes, and environmental controls
What else we look for (Preferred):
• Good computer skills in usage of MS Office and knowledge of Analytical Equipment System
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Moderate knowledge and understanding of Edwards policies and procedures relevant to microbiology
• Moderate knowledge and understanding of microbiology principles, theories and concepts
• Moderate understanding of at least one of the following areas: sterilization process, final release testing, and environmental controls
• Strict attention to detail
• 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
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
