Sterilisation Leadership Role
This is a leadership position in sterilisation, responsible for ensuring the highest standards of quality and compliance.
Key Responsibilities:
* Lead a team that conducts sterilisation qualifications for new and existing products
* Support supplier audits, manage validations for radiation and ethylene oxide (EO) sterilisation processes
* Conduct dose setting, dose audits, EO residual studies, and D-value studies to ensure accurate results
* Provide subject matter expertise support across product development and operations teams
* Manage investigations into dose audit failures and BI sterility positives to maintain quality standards
Requirements:
* Bachelor's degree in a scientific or technical field (Advanced degree an asset)
* Minimum 9 years of experience in sterilisation within medical devices or a regulated industry
* Expertise in radiation and/or EO sterilisation techniques and validations is essential
* Experience managing technical teams in a quality system environment is required
* Strong problem-solving, judgement, and cross-functional collaboration skills are necessary