Supervisor, Product Surveillance

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, Product Surveillance who will lead and motivate a staff of Product Surveillance Specialists and / or Product Surveillance professionals who are responsible for receiving, processing, analyzing, trending, and driving corrective action for product complaint issues in accordance with the requirements of 21 CFR 820 and ISO 13485:2016. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• Oversee and lead the activities of the Arthrex, Inc. Product Surveillance Specialists and /or Product Surveillance professionals as assigned by the Product Surveillance Manager.
• Coordinate global complaint handling activities between Arthrex, GmbH, Arthrex, Inc. and the subsidiaries.
• Motivate and empower the team to initiate and engage in continuous improvement activities.
• Foster a team environment where individuals work together to help each other with problem solving, workflow issues, and overcoming barriers to success.
• Champion the product recall, adverse events, and emerging issues processes; others as assigned.
• Coordinate field corrective actions between Arthrex and the FDA and other international regulatory agencies.
• Implement improvements to the Quality Management System and software as related to complaints, adverse events and product / field corrective actions.
• Assign projects, schedule work assignments, and train new employees.
• Assist in the administration of performance reviews and disciplinary action when necessary.
• Meet departmental process efficiency goals for all product complaints from receipt to closure.
• Interface with internal and external customers, including distributors, suppliers, healthcare professionals, engineering, marketing, regulatory, accounting, and legal departments to accomplish goals.
• Cover various department functions during times of short staff.
• Assure that systems and personnel keep pace with new requirements, techniques, workflows, and increased volume.
• Research and resolve business transaction conflicts.
• Maintain a current knowledge of regulations affecting the department.
• Provide status reports related to quality and efficiency goals.
• Participate in FDA, MDSAP, and international 3rd party audits and inspections as a department representative.

Education and Experience:

• Bachelor’s degree desired, preferably in an Engineering or a Science discipline.
• 3 years of progressive experience working in a Quality Assurance, Regulatory Affairs, or similar function

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

Working knowledge of ISO, FDA, MDD /MDR and international medical device / drug quality requirements. 

Excellent customer service skills required.

Demonstrated leadership qualities required– Leading by example, meeting challenges in a positive way, and a proactive, strategic mind-set.

Machine, Tools, and/or Equipment Skills:

Proficiency in Microsoft Office applications is required.

Knowledge of Pilgrim Smart Solve, Open Text Documentum, SAP and /or Agile is a plus.

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.

Arthrex 2024 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 or protected veteran status.