Sterilization Quality Control Specialist
hace 4 semanas
We are seeking a skilled Sterilization Quality Control Specialist to join our team at Carlisle Interconnect Technologies. In this role, you will be responsible for ensuring the quality of sterilized products and developing plans to comply with regulatory requirements.
Key Responsibilities:
- Develop and coordinate environmental and sterilization plans to meet regulatory standards.
- Provide support on sterilization validations, including protocol development and report writing.
- Maintain accurate records of environmental and sterilization processes in accordance with regulations.
- Develop and implement sampling plans for environmental and sterilization processes.
- Audit manufacturing and sterilization processes to ensure compliance.
- Coodinate CAPAs, NCMRs, and complaints related to sterilization and environment.
- Communicate effectively with customers regarding sterilization and environmental issues.
Requirements:
To be successful in this role, you should have a Bachelor's degree in Microbiology, Biochemical Engineering, or a related field. You must also have experience working in a medical manufacturing environment, knowledge of environmental/sterilization processes, and familiarity with ISO 13485:2016, CFR 21, Cofepris, and other relevant standards.
We offer a competitive salary range of $90,000 - $110,000 per year, depending on experience. Our benefits package includes health insurance, retirement plan, and paid time off. We are an equal opportunity employer and welcome applications from diverse candidates.
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