- 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.
- 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
- 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)
-
Supervisor - Product Surveillance
2 weeks ago
Arthrex Naples, United StatesRequisition ID: 60325 Title: Supervisor - Product Surveillance 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 ...
-
Supervisor - Product Surveillance
2 weeks ago
Arthrex Naples, United StatesArthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients BetterTM. We are committed to delivering uncom ...
-
Supervisor - Product Surveillance
2 weeks ago
Arthrex Naples, United StatesSupervise and lead the activities of the Arthrex, Inc. Product Surveillance Specialists and /or Product Surveillance professionals as assigned by the Product Surveillance Manager. Oversee the coordination of global Field Event activities among the Ar Surveillance, Product, Superv ...
-
Product Manager- Extremity
3 weeks ago
Arthrex Naples, United StatesEssential Duties and Responsibilities: · Participates in overall product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products. · Manages technical product development, estimates of potential profits, and r ...
-
Associate Product Manager, Knee
1 week ago
Arthrex Naples, United StatesEssential Duties and Responsibilities: · Participates in overall Knee Arthroscopy (Meniscus and Knee Alignment) marketing, product strategy, research and development requirements, development, and manufacturing coordination for new and emerging products. · Works on technical p ...
-
Product Manager, Knee
1 week ago
Arthrex Naples, United StatesRequisition ID: Title: Product Manager, Knee Division: Arthrex, Inc. (US 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 searchin ...
-
Completely Connected LLC Naples, United StatesJob Description · Job DescriptionWhat we are looking for: · We are looking for motivated people to join our team. We are looking for talented individuals familiar with Control4, eager to work and grow in our industry, able to deliver the absolute best for our clients, and willing ...
-
Sr. Product Manager- Extremity
5 days ago
Arthrex, Inc. Naples, United StatesRequisition ID: 60225 Title: Sr. Product Manager- Extremity & Trauma 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 ...
-
Sr. Product Manager- Extremity
3 weeks ago
Arthrex, Inc. Naples, United StatesRequisition ID: 59305 Title: Sr. Product Manager- Extremity & Trauma 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 ...
-
Sr. Product Manager- Extremity
1 week ago
Arthrex Naples, United StatesArthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients BetterTM. We are committed to delivering uncom ...
-
Sr. Product Manager- Extremity
1 week ago
Arthrex Naples, United StatesRequisition ID: 60225 Title: Sr. Product Manager- Extremity & Trauma 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 searchin ...
-
Product Manager, Fluid Management
1 week ago
Arthrex Naples, United StatesRequisition ID: 59371 Title: Product Manager, Fluid Management 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 within the orthopedic field. Our dynamic team is ac ...
-
Naples, FL SIU Investigator
3 weeks ago
Lemieux & Associates Naples, United StatesCome grow with us Lemieux & Associates, a national leader in the investigative industry, is seeking experienced SIU/Claims field investigators in the Naples or surrounding area. This is a part-time position to start with the ability to turn into a full-time position for the right ...
-
Lead Lifeguard
1 week ago
City of Naples, FL Naples, United States Full timeSalary: $ $27.36 Hourly · Location : Naples, FL · Job Type: Full Time · Job Number: · Department: Parks, Recreation & Facilities - Aquatic Center · Opening Date: 09/21/2023 · Closing Date: Continuous · FLSA: Non-Exempt · Bargaining Unit: A · GENERAL DESCRIPTION OF DUTIES ...
-
Associate Product Manager, Spine
1 month ago
Arthrex Naples, United States Full timeRequisition ID: 60086 Title: Associate Product Manager, Spine Division: Arthrex, Inc. (US01) Location: Naples, FL · Arthrex, Inc. stands as a prominent global medical device company, renowned for its advancements in orthopedic product development and medical education. Currently ...
-
Product Manager, Spine
1 month ago
Arthrex Naples, United States Full timeRequisition ID: 60081 Title: Product Manager, Spine 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 within the orthopedic field. Our dynamic team is actively sear ...
-
Inside IT Sales Specialist
3 weeks ago
Softrim LLC Estero, United States**Job Summary** · Softrim is a leading Technology Services provider that offers end-to-end technology solutions including Managed IT Services, Networking, Low-Voltage construction and design services, Life Safety, Surveillance, and more. We have offices in Estero FL, Alpharetta G ...
-
Lifeguard
1 week ago
YMCA OF COLLIER COUNTY INC Marco Island, United StatesPOSITION SUMMARY: YMCA can certify you · The Lifeguard position supports the work of the YMCA of Collier County, Inc., a leading not-for-profit organization committed to strengthening the communities in Collier County through its core focus areas of Youth Development, Healthy L ...
Supervisor, Product Surveillance - Naples, United States - Arthrex
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Requisition ID: 59721 Title: Supervisor, Product Surveillance Division: Arthrex, Inc. (US01) Location: Naples, FLArthrex, 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 BetterTM.
Essential Duties and Responsibilities:
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