Job Summary:
At Boston Scientific, we offer an exciting opportunity to lead a distributed team of scientists and engineers in the field of Sterility Assurance. As Associate Director, Sterility Assurance, you will be responsible for overseeing the qualification status of sterilization processes, investigating process deviations, and analyzing the impact of changes on sterility assurance.
Responsibilities:
* Lead a team responsible for ensuring the qualification status of all sterilization processes
* Investigate process deviations and non-conformances
* Drive projects related to sterilization process expansion and optimization
* Collaborate with cross-functional teams, including quality, regulatory, and R&D
Requirements:
The ideal candidate should have a bachelor's degree in Engineering, Microbiology, Biology, Chemistry, or a related discipline. A minimum of 10 years of experience in the medical device industry, with at least 5 years of direct people leadership experience, is required. Additionally, the candidate should possess expertise in microbiology, sterilization validation, and environmental controls. Experience interacting with regulatory authorities and competency in multiple industrial terminal sterilization methods are also essential. Preferred qualifications include a master's or PhD degree and additional technical areas such as reprocessing and laboratory operations.
Work Environment:
This role requires the ability to travel up to 20% of the time. We offer a dynamic and inclusive workplace where diversity and innovation thrive. By embracing unique backgrounds and perspectives, we create a better place for our employees to work and reflect the patients, customers, and communities we serve. We are proud to be an equal opportunity and affirmative action employer. If you require accommodations during the recruitment process, please contact us.