Edwards Lifesciences Manager, Microbiology & Sterilization (Quality Lab) in Irvine, California
Edwards’ Microbiology Quality Laboratory provides guidance, strategy, design and conducts studies for all related microbiological testing across a spectrum of our cardiovascular products. The Microbiology & Sterilization Manager will oversee Ethylene Oxide and Radiation sterilization for global Edwards’ medical devices and responsible for quality and compliance for EO and Radiation sterilization for Edwards’ global programs.
Responsible for quality and compliance for EO and Radiation sterilization for EW global program. Responsibilities include support for EO and Radiation sterility/bioburden, disinfection and cleanliness control program, and general microbiology lab oversight.
Recommends and approves procedures and validation protocols for sterilization microbiological testing and Process Challenge Device (PCD). Responsible for defining effective sterilization procedures and equipment qualification.
Develop and lead sterilization validation proposals, study documents, and guide their development to completion wherein decisions impact new products. Must be well versed in advanced microbiological technical principles, concepts, and implementation with compliance to ISO standards for sterilization.
A strong technical contributor and leader in the Quality organization. Deemed an expert in one or more areas with broad-based advanced knowledge within the organization. Maintains expertise in current and emerging regulations and trends and develops comprehensive quality and risk management systems to proactively address these requirements for sterilization and tissue. Recommends and executes changes to quality procedure to ensure conformance.
Project planning and execution of microbiological studies to support sterilization processes and acceptance. Proven project management skills.
Provides recommendations for Continuous Improvement and compliance of sterilization qualifications, in-house laboratory methods and validation of laboratory equipment. May consult with external sterilization companies. Drives the development of new and improved systems, processes, methods, for growth, compliance, and efficiency. Provide innovative solutions regarding parametric release.
Demonstrated success and work history of positive interactions with FDA, Notified Bodies, and other regulatory authorities. Provide support for RA submission and responses regarding to sterilization
Create a motivating and trusting environment to drive compliance to ISO 11135, 11137, 17665 and 17664. Ensure compliance to FDA, EPA, and other Regulatory Body standards.
Coordinates and supports resolution and investigation of nonconformances for global sites
Exercises wide latitude in determining objectives and approaches to critical assignments
Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
Additional responsibilities may be assigned to fulfill business needs.
Education and Minimum Requirements:
BS in Microbiology, or related scientific degree, with a minimum of 10 years of relevant medical device sterilization experience with concentration in Ethylene Oxide and Radiation
MS in Microbiology, or related scientific degree, with a minimum of 8 years of relevant medical device sterilization experience with concentration in Ethylene Oxide and Radiation
*At least four years of people leadership experience managing teams of 3+ direct reports
Proven technical skills with multiple sterilization processes
Sterilization experience supporting class III medical devices
Additional Talents and General Expectations:
Proven ability to manage multiple projects
Proven ability to generate solution to complex technical problems
Excellent problem-solving, organizational, analytical, and critical-thinking skills.
Excellent communication and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Must have demonstrated skills in the following areas: leadership, coaching, talent, and performance management.
Demonstrated success and work history of positive interactions with FDA, Notified Bodies, and other regulatory authorities.
Ability to travel up to 15% of the time
Balancing aggressive timelines and responsibilities while maintaining compliance with departmental and regulatory policies and procedures.
Providing accurate and timely information relevant to projects.
Interfacing with manufacturing from all BUs.
Being able to demonstrate flexibility and agility with constant changes in project prioritization and able to adapt to dynamic environment.
Ability to lead talent in a culturally diverse, matrixed organizational structure. Provides leadership to meet team objectives and scientific principles.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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 15,000 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.