Johnson & Johnson Careers

Associate Clinical Complaint Specialist (1 of 4)

Warsaw, Indiana
Quality Assurance

Job Description

Requisition ID: 3052180205

DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for four (4) Associate Clinical Complaint Specialist positions to be located in Warsaw, IN.


DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offers an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own


The Associate Clinical Complaint Specialist will be responsible for supporting the product complaint program by assessing medical/clinical information and assuming responsibilities which require medical/clinical expertise.   The Associate Clinical Complaint Specialist will work independently, and guide others, in decision making regarding MDR reporting of product complaints. This individual will also participate in special projects as assigned by management personnel and will provide feedback and suggestions for process improvement projects for optimization of the complaint handling system.


In addition, the Associate Clinical Complaint Specialist has the following duties:  Receives product complaint information and makes decisions regarding entry into the complaint database and whether to consider for MDR reporting; Reviews and assesses patient medical records for pertinent complaint information; Writes and approves investigation reports as delegated by complaint analysts or for certain, pre-determined, complaint categories;  Collaborates with the Clinical and Medical Safety Departments for review & assessment of product complaints resulting from clinical study sites; Leads and supports the facility in identifying and eliminating compliance risks; Provides support during internal and/or external audits; Prepares and/or reviews completed portions of regulatory submissions.


The Associate Clinical Complaint Specialist will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and applicable standards.  

  • A minimum of an Associate’s Degree in Nursing with a valid nursing license is required. 
  • A Bachelor’s degree is preferred.
  • A minimum of 2 years of practical nursing and/or clinical experience is required.
  • Experience in a GMP and/or ISO regulated environment is preferred.
  • Experience in medical device industry, preferably in orthopaedics, is preferred. 
  • Prior experience working directly with Complaint Investigations is preferred.   
  • Regulatory Affairs or Quality Assurance experience is preferred (particularly medical device records and regulatory reporting regulations). 
  • A broad knowledge of orthopaedic products and clinical applications of such products is preferred.
  • The ability to work independently on routine tasks with high attention to detail is required. 
  • Good communication skills, the ability to multi-task, strong organizational skills, and thrive on deadlines is required.  
  • Strong oral and written English communication skills are required, and fast keyboarding is essential.  
  • An ability to work cross functionally and promote good working relationships with other teams, to determine priorities, state challenges productively, and solve problems is required.
  • This position will be based in Warsaw, IN and requires up to 10% travel.

Primary Location
United States-Indiana-Warsaw
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality Assurance
Requisition ID