Microbiology Engineer - Sterilization
Location: Miami, FL
Working Situation: Hybrid
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.
Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Microbiology Engineer - Sterilization our manufacturing site. The Microbiology Engineer - Sterilization would be responsible for maintaining the Sterilization Facilities QMS requirements.
The Microbiology Engineer - Sterilization will be responsible for:
- Ensure timely and accurate completion of sterile load files for our products.
- 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.
- 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.
- Evaluate device compatibility with various sterilization modalities, ensuring adherence to applicable ISO requirements through microbiological and sterilization theory and practice.
- Willingness to travel domestically and internationally, up to 10% of the time.
The Microbiology Engineer - Sterilization 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 Microbiology Engineer - Sterilization opportunity, apply now!
