Posted in Science 30+ days ago.
Type: Full-Time
Requisition ID: | 47538 |
Title: | Biological Safety Specialist Sr |
Division: | Arthrex, Inc. (US01) |
Location: | Naples, FL |
Main Objective:
Maintain Arthrex, Inc.’s biological safety projects in accordance with Quality Systems Requirements.
Essential Duties and Responsibilities:
Knowledge: Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
Reasoning Ability: Develops solutions to a variety of complex problems. May refer to established precedents and policies.
Discretion/ Latitude: Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives.
Skills:
Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives.
• Knowledgeable of FDA and ISO guidelines for the biocompatibility assessment of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of biocompatibility test systems requirements.
• Hands on experience managing laboratory testing activities.
• Test protocol and report writing experience preferred.
• Working knowledge of device clinical use and associated harms and hazards
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Personnel supervision experience preferred
Education/ Experience:
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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