Manager - Microbiology & Laboratory Services

Date: Jan 11, 2023

Location: Ave Maria, FL, US, 34142

Company: Arthrex

 Requisition ID:                       57021                        
Title: Manager - Microbiology & Laboratory Services
Division: Arthrex, Inc. (US01)
Location: Ave Maria, 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 Manager – Microbiology & Laboratory ServicesManager who will oversee, manage, and provide direction to our Ave Maria, FL Biological Safety Laboratory and the AMIF EO Sterilization quality team to ensure a high level of regulatory compliance and quality related to sterility assurance and lab testing processes. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

 

Essential Duties and Responsibilities: 

  • Manage BSL laboratory and AMIF quality staff to ensure production and project support, while maintaining a high level of product/process quality and regulatory compliance.   
  • Responsible for performance management, recruitment, people/team development, and ensuring skills/training competencies are maintained. 
  • Develop, validate, and implement laboratory processes in accordance with regulatory requirements and business needs. 
  • Responsible for the Sterility Assurance and related Quality aspects of the in-house sterilization facility and process.
  • Support the Arthrex Manufacturing Inc Finishing EO Sterilization site in conducting EO Residual and BI Sterility tests, EO Load Validations, and QDAs for AMIE EO product families 
  • Maintain data quality, integrity, reporting, and workflows through the use of the laboratory information management system (LIMS), SAP, Agile, etc. 
  • Maintain laboratory operations in accordance with the Arthrex quality management system and all applicable regulatory requirements, international standards, and industry guidance. 
  • Ensure adequate maintenance, calibration, and validation of all laboratory testing equipment and stock sufficient inventory of material supplies for the performance of routine testing duties. 
  • Define, track, trend, and document laboratory performance and quality metrics, including non-conformances, turn-around time, capacity, and return on investment, for evaluation of laboratory performance. 
  • Optimize work instructions, testing procedures, and reports to ensure clear and efficient communication of testing requirements and results for manufacturing operations. 
  • Foster a positive mindset of continuous improvement, efficiency, and responsibility. 
  • Evaluates and develop improved quality techniques for the control of product activities 
  • Timely dispositions of Non-Conformances, Laboratory OOS, and Corrective Action issues 
  • Responsible for assuring the integrity and completeness of Testing Reports 
  • Support Arthrex’s business and expansion goals. 
  • Responsible for collaborating among all Arthrex sites and departments for the development of testing techniques and laboratory strategies that are geared to fiscal responsibility and operational efficiency.   

 

Education and Experience: 

  • Bachelor’s Degree in Science required (i.e., Chemistry, Microbiology, etc.) 
  • Minimum of 10 years sterility assurance and lab operations experience required.
  • 3+ years of experience managing sterility assurance and lab staff.
  • Med device manufacturing experience is preferred. 

 

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

In-depth knowledge of quality assurance techniques, practices, GLP, ISO 17025, and international testing standards (ASTM, USP, ISO, etc.).  Preferred knowledge of ISO 13485. Ability to manage a diverse department, and develop personnel in accordance with company objectives 

Machine, Tools, and/or Equipment Skills: 

Direct, hands-on, experience with sterile product release testing equipment, e.g., laminar flow hoods, incubators, gas chromatograms, and endotoxin measuring equipment. 

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

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 30 pounds.   

Vision Requirements: 

Visual acuity is 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 essential functions.

 

 

 

 

 

 

 

 

 

 

 

Arthrex 2023 Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
  • Eligible for discretionary Long Term Incentive program

 

 

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: Facilities, QA, Quality Assurance, Orthopedic, ERP, Operations, Technology, Quality, Healthcare