Sr. Manager, Sterilization Sciences and Biological Safety

Date: Jan 31, 2023

Location: Naples, FL, US, 34108

Company: Arthrex

Requisition ID: 55804 
Title: Sr. Manager, Sterilization Sciences and Biological Safety 
Division: Arthrex, Inc. (US01) 
Location: Naples, FL

 

 

 

 

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 Senior Manager, Sterilization Sciences and Biological Safety for our Naples, FL Corporate Headquarters. The Sr Manager will manage and maintain Arthrex’s Manufacturing sterilization and biocompatibility projects in accordance with Quality Systems Requirements and to assure validations of special processes at all Arthrex and Supplier locations.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  

Essential Duties and Responsibilities: 

 

  • Manage team of sterilization and biological safety specialists in the maintenance of product safety requirements related to biocompatibility and product sterility; 
  • Develop and maintain state-of-the-art processes and systems for the assessment of biocompatibility and maintenance of test programs and data in accordance with the ISO 10993 compendium of standards; 
  • Direct and coordinate sterility assurance staff in release of products from internal and contracted sterilization processes and documented evidence related to the maintenance of process effectiveness; 
  • Foster an environment of active participation within the broader medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT; 
  • Oversee global sterilization process providers (EO and Gamma) to ensure appropriate cycle maintenance activities are completed in a timely manner and meet international standard requirements, e.g., ISO 11135 and ISO 11137; 
  • Consult on programs to support manufacturing and global contractors in routine monitoring and trending activities related to critical manufacturing processes and environments e.g., cleaning systems, clean rooms, etc.; 
  • Lead and perform sterilization and biological safety assessments related to new product development and internal / supplier proposed processing changes; 
  • Manage the global sterilization release program to ensure a high quality and fast release of product to the market to meet both business goals and patient safety requirements.  
  • Support Arthrex Biological Safety Laboratory testing operation and strategy to maximize the “In-House” program-based testing according to the various methodology requirements (e.g., AAMI, ISO, USP, etc.) 
  • Support and develop Biological Safety Laboratory personnel to expand on their testing knowledge and capabilities and on the various aspects of biological safety of medical devices. 
  • Support Biological Safety Laboratory Specialists to develop new test methodologies, improve process and efficiency. 
  • Lead Arthrex EO sterilization facility quality staff to coordinate product release, sterilization related projects, validations, and team development.      
  • Mentor teams, share experience, and provide best practices to biological safety / quality staff related to biological safety & sterilization systems, corporate policy, and regulatory requirements; 
  • Manage audits, audit responses, and required documentation as generated by internal audits and notified body / regulatory auditing groups; this to include any generated CAPAs or preventive action measures resulting from the audit; 
  • Support and lead Arthrex’s business and expansion goals; 
  • Track, trend, and document metrics, including non-conformances, for management review meetings. 

 

 Education and Experience: 

 

  • Bachelor’s Degree required; preferably in a physical science 
  • 3 years experience in a Quality Assurance position required 
  • 5 years experience in sterilization and process validations required 
  • 3 years previous supervisory experience required 

 

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

In-depth knowledge of quality assurance techniques, practices, ISO and Global Regulatory (FDA, JMHLW, CMDCAS, ANIVSA, etc.) compliance.  Ability to manage diverse department, and develop personnel in accordance with company objectives 

 

Machine, Tools, and/or Equipment Skills: 

Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), SAP, Oracle. 

 

Reasoning Ability: 

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. 

 

Mathematical Skills 

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.   

 

Language and Communication Skills: 

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.  Ability to verbally communicate ideas and issues effectively to other team members and management.  Ability to write and record data and information as required by procedures. 

 

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to talk or hear.  The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.  To bend frequently and lift 50-70 lbs. on a regular basis. 

 

Vision Requirements: 

Visual acuity necessary to do the job safely and effectively.   

Specific vision abilities required by this job include close vision. 

 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   

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.


Nearest Major Market: Naples

Job Segment: Medical Device, Quality Assurance, QA, Facilities, Product Development, Healthcare, Technology, Quality, Operations, Research