Supervisor Biocompatibility (Finance)

Requisition ID: 63174 Title: Supervisor Biocompatibility 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 Supervisor, Biocompatibility for our Global Headquarters in Naples, FL. The Supervisor will manage and maintain Arthrex Design and Manufacturing Biocompatibility projects in accordance with all applicable Regulatory and Quality Systems Requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Supervise and lead the Biocompatibility team in the development and management of 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 requirements in an efficient, cost-effective, and business results-driven manner;
• Lead and perform the authoring and execution of biocompatibility assessments related to new product development, new market expansion, as well as internal and supplier proposed process / material changes;
• 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, ISO 10993 series and international regulatory directives;
• Manage biological safety-related audits, audit responses, and required documentation as generated by internal audits and notified body / regulatory auditing groups; this to include any CAPAs or preventive action measures resulting from the audit;
• Actively represent Arthrex and the medical device industry through active involvement in international standards committees such as AAMI, ISO, and SOT;
• Mentor teams, share experience, and provide best practices to biological safety/quality staff related to biological safety systems, corporate policy, and regulatory requirements;
• Encourage and foster an environment with a foundation of continuous process improvement and industry benchmarking.

Education and Experience:

• Bachelor's Degree required; degree in a physical science preferred
• 7 years experience in biological safety 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, ANVISA, etc.) compliance. Ability to manage a 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.

W ork 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.

Arthrex 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.