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Complaints Specialist III (1 of 6) Job

Company Name:
Depuy Orthopaedics. Inc. (6029)
Palm Beach Gardens, FL, US
Johnson & Johnson companies are equal opportunity employers.
Complaints Specialist III (1 of 6)-6841140321
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Complaints Specialist III (1 of 6), located in Palm Beach Gardens, FL.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies 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, more agile and better equipped to meet the needs of today? 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 Complaints Specialist III will be responsible for supporting Complaint Handling, MDR and Post Marketing Surveillance activities. He/she may be involved in Non-Conformance Investigations, Field Actions, Documentation Management and Metrics. This individual will be responsible for the oversight and direct support of technical evaluations, and investigational tasks required for complaint processing/closure. The Complaints Specialist III will communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.
The Complaints Specialist III will directly interface with Hospitals, Surgeons, and Internal DePuy Synthes employees for reporting of complaints and adverse events. He/she will prepare for and attend MDR team meetings on behalf of the Complaint Handling Unit. This individual will be reporting Initial and Supplemental MDR?. The Complaints Specialist III will provide guidance and direction to peers as well as be involved in the field action and complaint handling process. The Complaints Specialist III will prepare weekly and quarterly complaint handling reports. He/she will be responsible for processing and closing complaints in a timely manner. This individual will maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals. The Complaints Specialist III will be required to know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times. He/she will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Qualifications
A minimum of a Bachelor? Degree in Nursing, Life Sciences or Health Sciences is required. A minimum of 6 years of professional experience is required. A minimum of 4 years in a GMP and/or ISO regulated industry strongly preferred. A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is also strongly preferred. Experience in post market regulatory, quality or compliance areas is preferred. The ability to work independently and prioritize with little supervision is required. Strong written and oral communication and interpersonal (listening) skills is required. The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required. Familiarity with basic quality tools and techniques is preferred. Analytical and critical thinking skills are required. Excellent organizational and time management skills are required. RAC or ASQ certifications are preferred. Strict attention to detail is required. This position will be based in Palm Beach Gardens, FL and requires up to 10% travel, with a potential for international 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.
J2W: LI NA
Primary Location:
North America-United States-Florida-Palm Beach Gardens
Organization:
Depuy Orthopaedics. Inc. (6029)
Job Function:
Quality (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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