Customer Complaints Specialist II - Quality

Job description

Job Description

Requisition ID: 7261181113

DePuy Synthes part of the Johnson & Johnson Family of Companies is recruiting for a Customer Complaints Specialist II - Quality located in Palm Beach Gardens, FL.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visitwww.depuysynthes.com .

The Customer Complaints Specialist II - Quality will be responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions, which may include Non-Conformance Investigations, Field Actions, Documentation Management and Metrics. The Complaint Specialist II will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Complaint Specialist II will communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.

You will:

• Interface directly with Hospitals, Surgeons, and Internal Synthes employees for reporting of complaints and adverse events.
• Prepare for and attend MDR team meetings on behalf of the Complaint Handling Unit.
• Handle reporting Initial and Supplemental MDRs.
• Provide guidance and direction to peers; serve as expert in field action and complaint handling process.
• Prepare updates to FDA for Open Field Actions.
• Respond to external questions regarding field actions.
• Serve as internal expert regarding open field actions.
• Prepare Weekly and Quarterly Complaint Handling Reports.
• Responsible for processing and closing complaints in a timely manner.
• 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.
• 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.
• Diligently participate in our compliance program-related activities as denoted by your Supervisor or our Chief Compliance Officer.

Desired profile

Qualifications
• A minimum of a Bachelor's Degree or equivalent is required.
• A minimum of two (2) years of experience in a GMP and/or ISO regulated environment is required. Experience in the medical device and/or pharmaceutical industry preferred. Previous MDR experience preferred.
• The ability to work independently and prioritize with little supervision required.
• Strong written & oral communication and listening skills required.
• The ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making is required.
• Experience in post market regulatory, quality or compliance areas is preferred.
• 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.
• This position is located in Palm Beach Gardens, FL and may require up to 10% travel.

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-Florida-Palm Beach Gardens-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Generalist)
Requisition ID
7261181113

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