Manager, Sterilization & Biocompatibility

LeMaitre•Burlington, MA

1d•$130,000 - $175,000

About The Position

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.

Requirements

Bachelor's degree in microbiology or biology required.
5 years related experience in ISO regulated industry.
2 years People management experience.
Knowledge of cGMPs.
Microsoft Office.

Nice To Haves

Medical Device experience preferred.

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 policies, procedures, and documentation requirements.
Treats others with courtesy, sensitivity, and respect at all times.
Other duties as assigned
Sets goals and provides clear direction.
Provides training, coaching, feedback, and recognition.
Responds to employees’ needs and questions as needed.
Supports employee’s career goals and development.
Communicates updates to your employees in a timely manner.
Addresses employee concerns immediately.
Addresses performance and behavior issues appropriately.