Biocompatibility Specialist II

Arthrex•Pelican Bay, FL

1d•Onsite

About The Position

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Biocompatibility Specialist II for our Global Headquarters in Naples, FL. The Biocomp Specialist II is responsible for maintaining Arthrex, Inc's biological safety projects in accordance with Quality Systems Requirements. The ideal candidate will have a BS in Chemistry, Biology, or Toxicology along with 2 years relevant experience. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Bachelor’s Degree in Chemistry, Toxicology, Biology, or related science field required.
2 years relevant experience required

Nice To Haves

Previous project management experience preferred.
DABT Certification Preferred.
Specialized training in manufacturing operations, system design and development, terminal sterilization methods, industrial statistics, and technical writing preferred.
Experience in project management tools are highly desirable.
Experience in working with Toxicological Risk Assessments, Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting preferred.

Responsibilities

Develop and manage internal programs, with a global perspective, on biological safety risk assessment, toxicological risk assessments, testing plans / strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO 10993, FDA Guidance, and global regulatory requirement;
Participate in design review meetings as a key member of new product design teams to assess products for biocompatibility and related biological safety concerns, including documentation of biological safety assessments, test plans, and associated reports;
Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT;
Manage the appropriate maintenance, review, and gap analysis / impact assessment of external standards, regulatory requirements, and guidance’s associated with biological safety;
Function as lead auditor and/or subject matter expert for quality management system audits of Arthrex’s global laboratory service providers in accordance with applicable standards, e.g., ISO 13485, ISO/IEC 17025, and international regulatory directives;
Mentor teams, share experience, and provide best practices to biological safety/quality staff related to biological safety systems, corporate policy, and regulatory requirement;
Encourage and foster an environment based upon a foundation of continuous process improvement and industry benchmarking;
Support and lead Arthrex’s business and expansion goals;
Must be able to travel domestically and internationally up to 10% of the time