Manager, Sterilization & Biocompatibility

Job description

Overview This position serves as the technical leader in Sterilization and Biocompatibility. Provides innovation for new sterilization technologies, implements efficiencies and upgrades systems based on new standards. Responsibilities: - Provides technical leadership on microbiology, sterilization, and biocompatibility for the different LeMaitre manufacturing facilities. - Manages Quality Engineers and support their day-to-day activities, projects, and validations. - Collaborates with Manufacturing and R&D project teams to assess the impact of the process or product change. - Supports internal and external audits as an SME in microbiology, sterilization, and biocompatibility. - Creates quality plans for the impact assessment of changes applicable standards ex. ISO13408, ISO14160, ISO11135, ISO11137, ISO10993, ISO22442. - Provides planning support for cleanroom and building expansions including aseptic processing. - Updates procedures with the introduction of new products or facilities. - Develop goals for the team that foster innovation and efficiency in the department. - Maintains a working knowledge of government and industry regulation and standards. - Adheres to company policie...