Johnson & Johnson Careers

Complaints Specialist (3 Openings)

Irvine, California
Quality Assurance


Job Description

Requisition ID: 0717190329

Mentor, a member of the Johnson & Johnson Family of Companies, is looking for a Complaints Specialist.

Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.

The Complaints Specialist will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards. The candidate will review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world. The candidate will also ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting. The individual applies standard practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.

As a Complaints Specialist, you will:
  • Be responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
  • Be responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
  • Evaluate all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
  • Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
  • Understand basic principles, theories, concepts and techniques related to customer complaints.
  • Escalate critical issues for proper disposition as necessary.
  • May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
  • Ensure compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertaining to medical devices.
  • Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Support Product Analysis Evaluation if required.
  • Perform other duties assigned as needed.

Qualifications
  • Bachelor’s Degree in a technical science discipline plus at least 2 years of recent experience in a medical device complaint team, or an equivalent combination of education and experience is required.
  • Experience handling reportable complaints is preferred.
  • Working knowledge of international standards and regulatory requirements, including, but not limited to ISO 13485 and 21 CFR, section 803 and 820 is preferred.
  • Excellent written and verbal communication skills are required.
  • Demonstrated attention to detail is required.
  • Ability to work independently as well as in a team environment is required.
  • Strong organizational and analytical skills with the ability to multitask and consistently handle multiple projects with stringent deadlines concurrently is required.
  • Proficiency in MS Office Suite is required.
  • Technical aptitude and ability to explain technical information in a clear and concise manner is required.
  • Analytical problem solving – ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify data-driven root causes is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-California-Irvine-
Organization
Biosense Webster Inc. (6010)
Job Function
Quality Assurance
Requisition ID
0717190329