Biological Safety Specialist II (R&D)
Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Biological Safety Specialist II to join its Biological Safety team at our site in Naples, FL. The Biological Safety team is responsible for developing and maintaining a state-of-the-art biocompatibility program which ensures compliance of projects in accordance with quality system regulations. These regulations help to support the Arthrex corporate goals which focus on: new product development, global standard implementation, domestic and international regulatory compliance and process and cost efficiencies. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
Essential Duties and Responsibilities:
Education & Experience: 3 Years with BS Degree in Engineering, biology/microbiology, chemistry, toxicology or related science field
Knowledge: Frequent use and general knowledge of industry practices, techniques, and standards. General application of concepts and principles.
Reasoning Ability: Develops solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
Discretion/Latitude: 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 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.
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.