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. In this role you will address complex compliance and risk assessment activities related to new product development and manufacturing sustaining activities as it relates to contamination control and sterility assurance.

How you will make an impact:
• Qualify complex laboratory instrumentation and validate complex test methods while applying microbial knowledge and concepts to perform environmental control testing, in-process solutions, and final product release testing for device qualifications
• Lead in the development of complex technical protocols, reports, and methods in collaboration with intra and inter-departmental teams
• Provide strategy and guide other microbiologists on root cause analysis for product/sample failures, Out-of-Specifications (OOS), non-conformances investigations
• Train, coach, and guide lower level employees on complex equipment and test methods, assess work techniques and provide feedback on policies and procedures
• Lead laboratory manufacturing sustaining operations activities including maintaining work schedules to align with production
• Provide solutions and lead in the validation of new laboratory equipment
• Lead complex critical system improvement projects (e.g. BEST, Lean) and work with team to provide solutions
• May be a on a working group/committee in support of a compliance guide
• Other incidental duties:

What you'll need (Required):
• Bachelor's Degree in Microbiology or related Science degree, 8 years’ related experience 
• Laboratory experience in a regulated environment

What else we look for (Preferred):
• Proven successful project management skills
• Proven expertise in MS Office
• Excellent facilitation and presentation skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• 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
• Extensive knowledge and understanding of Edwards’ policies and procedures relevant to microbiology which includes contamination control and sterilization.
• Thorough knowledge of the compliance guides for environmental controls or a sterilization process
• Extensive knowledge and understanding of Microbiology principles, theories and concepts.
• Extensive knowledge of laboratory equipment.
• Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
• Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Excellent written and verbal communications skills
• Advanced problem-solving skills
• Ability to manage confidential information with discretion
• Strong leadership skills and ability to influence change
• 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
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to work in a team environment, including frequent inter-organizational and outside customer contacts
• Ability to represent the organization in providing solutions to difficult technical issues associated with specific projects