Senior Sterility Assurance Specialist
Location: Gainesville, FL
Working Situation: Onsite
Level: Associate Level
Join a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth. Be part of a team where your expertise and passion will drive impactful advancements in medical technology
We are looking for a dynamic Senior Sterility Assurance Specialist to join a leading global medical device company known for its innovative product development. In this role, you will be responsible for ensuring compliance with Quality Management System (QMS) requirements at our manufacturing facility. If you're passionate about quality assurance and want to contribute to industry-leading advancements, we want to hear from you!
The Senior Sterility Assurance Specialist will be responsible for:
- Oversee the Sterile Release program for produced loads, ensuring safe and prompt product release to meet customer demands.
- Address Non-Conformances observed during sterilization processes for the facility, including opening, evaluating, and closing such cases to resolve affected loads.
- Collaborate with Sterilization Facility Personnel to investigate Non-Conformances, identifying root causes and implementing preventive measures.
- Support process improvement initiatives within the Sterilization Facility program.
- Maintain procedures pertaining to Quality Assurance - Sterilization department activities, including reviewing related procedures and records.
- Serve as a lead auditor and/or subject matter expert for quality management system audits of sterilization service providers, in compliance with relevant standards such as ISO 13485, ISO 11135, and ISO 11137.
- Develop and execute protocols for sterilization processes and equipment validation/re-validation, including generating comprehensive reports and conclusions.
- Coordinate all activities related to sterilization validations and testing, liaising with external and corporate laboratories, as well as sterilizer personnel.
- Willingness to travel domestically and internationally, up to 10% of the time.
The Senior Sterility Assurance Specialist will have the following qualifications:
- Bachelor's degree in Engineering, Biology/Microbiology, Chemistry, Toxicology, or related scientific field.
- Minimum of 2 years of relevant experience.
- Experience with Sterilization Processes (Ethylene Oxide (EO), Gamma, X-Ray)
If you are interested in the Senior Sterility Assurance Specialist opportunity, apply now!
