Purpose Statement
Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all the regulations governing sterilization. Works in partnership with Global Sterility Assurance, to meet the sterilization needs of the Penang site. Primary contact for DES PU and IPF platform to interface with Sterilization supplier, GSA and Active Release partners.
Key Responsibilities
Supports Sterilization validations (EO and irradiation) for Penang Site.
Supports Sterilization regulatory and compliance activities at Penang Site.
Supports Sterilization submissions to regulatory bodies.
Key Sterilization person at sites during external audits.
Key role in conducting audits of Sterilization vendors and facilities.
Liaise with Contract sterilization providers in addressing deviations and/or downtime.
Regular communication with Global Sterility Assurance Organization.
Compliance to internal BSC procedures and GMP practices.
Good knowledge of MDD and FDA requirements.
Good knowledge of EO E-Beam and Gamma Sterilization.
Knowledge of Sterilization and Quality System Standards.
Plans and coordinates sterilization evaluations requests from Penang site.
Management and preparation of dunnage's for sterilization activities
Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
Serves as a resource in the orientation and training of new engineers and employees. May lead a project team, determining goals and objectives for the projects. Mentors employees by sharing technical expertise and providing feedback and guidance.
Job Requirements:
Candidate required process at least Bachelor Degree in science/engineering.
At least 2 -5 years of working experience in related field.
Knowledge: EO/irradiation/E-Beam sterilization, cGMP, Combination Device Regulations and other Sterilization related regulations.
Candidate from medical industry will be preferable.
About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
