Quality Assurance Specialist II - Sterilization
Arthrex Manufacturing Inc
Ave Maria, FL
Maintain Arthrex, AMI – Finishing Facility's quality assurance program in accordance with Quality Systems Requirements.
Essential Duties and Responsibilities:
- Ensure proper and timely accurate completion of sterile load files of Arthrex Manufacturing Inc. products;
- Maintain the Sterile Release program for loads produced by Arthrex Manufacturing Inc. and ensure timely and safe product release to meet customer requests;
- Report and act by opening, disposition, evaluating, and closing on Non Conformances observed during sterilization processes for Arthrex Manufacturing Inc. to provide a resolution for the disposition of affected loads;
- Support the AMI - Finishing Facility Personnel to investigate on Non Conformances related to sterilization processes to determine the root cause and prevent re-occurring issues;
- Support the AMI – Finishing Facility program to identify and encourage process improvement;
- Maintain procedures related to the Quality Assurance – Sterilization department activities and review procedures and records related to the AMI – Finishing Facility Sterilization processes;
- Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex's sterilization service providers in accordance with applicable standards, e.g., ISO 13485, and international regulatory directives;
- Generate and execute protocols for sterilization processes (i.e. EO, Gamma, etc.) and equipment validation and re-validations, along with reports and conclusions;
- Manage all activities related to sterilization validations and/or testing, and directly interact with external and corporate laboratories, and sterilizers personnel to accomplish the assigned tasks;
- Assess devices for compatibility to proper sterilization modalities, e.g., radiation, ethylene oxide, by validating and/or adopting Arthrex manufactured products to established or new families using microbiological and sterilization theory and practice according to applicable ISO requirements;
- Effectively work within a cross functional team environment as both a champion and team member;
- Support Arthrex business and expansion goals;
- Must be able to travel domestically and internationally up to 10% of the time
Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Works under very general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
• Knowledgeable of FDA and ISO guidelines for the sterilization modalities of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of sterilization test systems requirements.
• Hands on experience managing sterilization product assessments and validations.
• Test protocol and report writing experience.
• Knowledge of ISO 13485 guidelines and principles of quality requirements
• Experience with CAPA processes and non-conformance investigation techniques to determine root-cause
BS Degree in Engineering, biology/microbiology, chemistry, toxicology or related science field
Experience in an FDA /ISO regulated environment.
Previous project leadership experience preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable. Experience in working in Medical Device industry, CAPA, Complaint Management, and Nonconformance Reporting required.
Machine, Tools, and/or Equipment Skills:
Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company). SAP and / or Pilgrim Quality Data experience desirable.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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