Environmental Control Specialist
hace 2 semanas
We are seeking a highly skilled and experienced professional to lead our environmental control and sterilization efforts. As the Sterilization Process Manager, you will be responsible for overseeing the activities of your team in the environmental control and sterilization area, ensuring compliance with quality standards and procedures.
Main Responsibilities:
- Supervise team members in the environmental control and sterilization area to ensure adherence to quality procedures.
- Promote continuous improvement by applying environmental assessment techniques and maintaining a high-quality system.
- Maintain all ethylene oxide chambers revalidated and coordinate with customers for revalidation needs.
- Develop and execute validation strategies for new products sterilized by ethylene oxide or radiation.
- Evaluate root causes of sterilization and environmental control issues and provide support to associated departments.
- Ensure control and maintenance of compliance with biological load verification programs and dose audits.
Requirements:
To succeed in this role, you must have a strong background in science, chemistry, microbiology, or a related field. Additionally, knowledge of sterilization and environmental standards, such as ANSI/AAMI ISO 11135 and ISO 14644, is essential. Experience with QSR-21 CFR Part 820 and ISO 13485 Quality System standards is also desirable. Internal auditor certification, quality engineer certification, and biomedical auditor certification are preferred qualifications.
Benefits:
As a member of our team, you can expect a competitive salary, excellent benefits package, and opportunities for professional growth and development.
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