HireDiversity

Warsaw, IN, US

Complaints Analyst III - Materials-8075121026

Description

DePuy Synthes Companies of Johnson & Johnson is currently recruiting for a Complaints Analyst III - Materials for Warsaw, Indiana.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer 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.

DePuy Orthopaedics is the Joint Reconstruction business offering orthopedic devices, solutions and supplies for hip, knee and extremity reconstruction, in addition to cement and operating room products.

The Complaints Analyst III - Materials would be responsible for the materials related aspects of product investigations, including failure analysis, material characterization and measurements. The Complaints Analyst III - Materials is responsible for supporting the product complaint program including initial complaint assessment and identification of complaints related to adverse events. The Complaints Analyst III - Materials analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions to customer issues by working interactively with cross functional teams. In addition, the Complaints Analyst III - Materials has the following duties: (1) Collaborates with other groups such as engineering, clinical, regulatory, research and marketing to ensure a thorough and accurate complaint investigation; (2) Coordinates and participates in the evaluation of returned products; (3) Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure; (4) Investigates and documents complaints; (5) Leads and supports the facility in identifying and eliminating compliance risks; (6) Partners with appropriate functional departments to achieve effective corrective action; (7) Prepares and/or reviews completed portions of regulatory submissions; (8) Reviews complaint files for accuracy and completeness; (9) Serves as a liaison between the quality assurance department and other departments to ensure timely and accurate completion of complaint investigations; (10) Summarizes results and makes suggestions for changes; and (11) Prepares responses to customer inquiries regarding complaint investigations and prepares trend reports for complaints.

Under minimum supervision, the Complaints Analyst III - Materials is 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. This individual evaluates all information from a materials and technical perspective to ensure appropriate Root Cause analysis and investigation, and that any appropriate actions are undertaken and documented.

Qualifications


A minimum of a Technical Degree (BS or an equivalent) is required. An Advanced Degree in a related discipline and/or further training or certificates (especially medical or statistical) is preferred. A minimum of 6 years of experience in a medical device industry is required. Experience in orthopaedics is preferred. Experience in failure analysis and material science is preferred. Prior experience working directly with Complaint Investigations is an asset. The successful candidate must be able to work independently on routine tasks with high attention to detail. Good communication skills, the ability to multi-task, strong organizational skills, and thrive on deadlines is required. An American Society for Quality (ASQ) certification, Six Sigma experience, knowledge of Process Excellence tools and/or Oracle Databases is preferred. Proficiency in the Microsoft Office suite of products 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 is located in Warsaw, IN and requires up to 10% travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)
Relocation: Eligible
Yes - Within Country
Travel:Yes, 10% of the time