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Senior Complaint Analyst
Somerville, New Jersey
Requisition ID: 6923180323
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Complaint Analyst, this role is in Somerville, NJ.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal.
You, the Senior Complaint Analyst will prepare and submit timely reports to meet FDA requirements, including 3500A forms, Baseline reports, and Alternative Summary reports.
- Effectively question customers, Sales Reps, etc. to capture accurate product & event information, during every contact while maintaining a positive experience
- Accurately input product complaint information into Complaint Management System.
- Review complaint data and determine MDR reportability.
- Provide appropriate customer correspondence, as needed
- Review complaint analysis to ensure adequacy and customer resolution
- Provide information to aid in the creation and management of corrective action plans and nonconformance reports.
- Escalate critical/urgent issues to appropriate individuals as needed.
- Provide adequate customer service with accurate information in a courteous and timely manner to help drive strong customer satisfaction
- Ensure confidentiality of patient & customer information, as well as company confidential and proprietary information, during all customer interactions
- Assisting in audit and compliance review processes.
Principle Duties include:
- Demonstrating world class customer support and maintaining knowledge of ETHICON products and services.
- Assessing, processing and closing complaint data related to Ethicon’s portfolio of internally and externally manufactured products in accordance with associated complaint handling procedures and WCQ expectations.
- Participating in and leading assigned projects supporting desired business outcomes.
- Promoting a work environment that challenges the status quo, leading and adapting to change, as well as creating significant positive changes in the workplace.
- Creating a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.
- Maintaining and updating current WCQ Complaint Analyst quality system policies and procedures.
- Bachelor’s degree is required with medical, technical or business focus (Registered Nurse or Biomedical Engineer ideal) is preferred.
- 4 years customer service/call center environment experience is required
- Comprehensive Knowledge of medical terminology & surgical devices preferred.
- Knowledge of Medical Device Reporting is required.
- Desirable to have knowledge of statistical applications and auditing practices is preferred.
KEY SKILL / KNOWLEDGE REQUIREMENTS:
- Investigative & analytical critical thinking skills.
- Strong decision-making skills – able to make sound business decisions with sometimes limited information.
- Effectively manages work & time to produce desired outcomes (time management).
- Able to multi-task and adequately deal with sudden changes in priorities.
- Strong written and verbal communication skills – specifically with the ability to effectively communicate with individuals in a clear, concise & effective manner.
- Knowledge of applicable quality, FDA (Food & Drug Administration) & ISO (International Organization for Standardization) requirements is required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Somerville
Ethicon Inc. (6045)