Job Information
Actalent Sterilization SME in Portage, Michigan
Job Title: Microbiology Specialist
Job Description
Join our dedicated team as a Sterilization SME, where you will play a crucial role in ensuring the safety and efficacy of medical devices. This position involves close collaboration with R&D, Regulatory Affairs, Quality, and Microbiologists.
Responsibilities:
Integrate and remediate products as necessary, to align with technical standards criteria related to cleaning, disinfection, and sterilization
Collaborate with Quality, R&D, Regulatory Affairs, Test Technicians as well as external regulatory bodies to drive state of the art products and processes
Develop technically sound protocols, reports, and verification summaries in collaboration with cross-functional teams and laboratories
Ensure compliance with global regulatory requirements and standards related to reprocessing such as ISO 17664, ISO 17665-1, ISO 15883 series, AAMI TIR 12 and AAMI TIR 30
Ensure reprocessing instructions meet country specific requirements (e.g. UK, Germany, France, etc.)
Deliver on EU MDR requirements relating to cleaning, disinfection and sterilization of reusable medical devices
Creation of a database/information repository to capture all validation data and further establish processes and procedures in this area
EO and Radiation sterilization assessments on product and packaging changes
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.