Senior Quality Assurance Specialist
7 hours ago
We are seeking a highly skilled Quality Assurance Specialist II to join our team at DSJ Global. As a key member of our quality assurance team, you will be responsible for ensuring compliance with quality management system requirements at our manufacturing facility.
Key Responsibilities:
- 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.
- 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.
Requirements:
- 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)
Preferred Qualifications:
- Familiarity with FDA and ISO guidelines for medical device sterilization modalities.
- Understanding of manufacturing processes is advantageous.
- Preferably trained in project management and communication skills.
- Working knowledge of sterilization test systems requirements.
- Hands-on experience in managing sterilization product assessments and validations.
- Proficiency in writing test protocols and reports.
- Knowledge of ISO 13485 guidelines and principles of quality requirements.
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