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Sr Biological Safety Specialist in Naples, FL ,  at Arthrex

Date Posted: 8/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/3/2018

Job Description


Requisition ID:
41407
Title:
Sr Biological Safety Specialist 
Division:
Arthrex, Inc.
Location:
Naples, FL

Main Objective:

Maintain Arthrex, Inc.’s biological safety projects in accordance with Quality Systems Requirements.

Essential Duties and Responsibilities:

  • Develop and manage internal programs, with a global perspective, on biological safety risk assessment, 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 15% of the time

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

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

7 Years experience in an FDA /ISO regulated environment, relevant experience in biocompatibility assessment of medical devices or similarly regulated products

BS Degree in Engineering, biology/microbiology, chemistry, toxicology or related science field. MS Preferred

Previous project leadership experience required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Experience in project management, risk management (such as FMEA, FTA, FMECA) required. 

Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting required. 

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.