Quality Engineer
hace 3 semanas
Job Summary
Carlisle Interconnect Technologies is seeking a Quality Engineer - Sterilization and Environmental Specialist to develop and coordinate environmental and sterilization plans to comply with applicable regulations. This role will provide support on environmental and sterilization validations, including protocol development and report generation. Additionally, the successful candidate will be responsible for maintaining environmental and sterilization records, auditing processes, and coordinating corrective actions.
Responsibilities
- Develop and coordinate environmental and sterilization plans to ensure compliance with applicable regulations.
- Provide support on environmental and sterilization validations, including protocol development and report generation.
- Maintain environmental and sterilization records in accordance with applicable regulations and licenses.
- Audit environmental, manufacturing, and sterilization processes to ensure compliance.
- Coordinate and follow up on corrective actions related to sterilization and environmental issues.
- Provide support to quality management systems plans.
- Contribute to safety initiatives and related programs.
Requirements
Minimum Requirements:
- Bachelor's degree in Microbiology, Biochemical Engineering, QFB, or similar field.
- Experience in medical manufacturing environment conditions and controls.
- Knowledge of environmental and sterilization processes and applicable standards.
- Knowledge of ISO 13485:2016, CFR 21, Cofepris, and other applicable standards.
- Bilingual, English 80%.
- Teamwork focus, proactive, and internal auditor ISO 13485:2016 certified.
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