Johnson & Johnson Careers
Customer Quality Specialist II
Palm Beach Gardens, Florida
Requisition ID: 0765190401
DePuy Synthes, part of the Johnson & Johnson Family of Companies is recruiting for a Customer Quality Specialist II.
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, visit www.depuysynthes.com.
You, the Customer Quality Specialist II will be responsible for the oversight and direct support of complaint processes, technical evaluations, and investigational tasks required for processing/closure. This role will likewise offer collaboration with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.
• Supports the product complaint program including initial complaint assessment and identification of complaints related to adverse events.
• Analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions to customer issues.
• Diligently participate in our compliance program-related activities as denoted by your Supervisor or our Chief Compliance Officer.
• Required to know and follow all laws and policies that apply to one's job, and maintain the highest levels of integrity, ethics and compliance at all times.
• Responsible for processing and closing complaints in a timely manner.
• Handle assigned projects in conjunction with project teams in a complex, highly-matrixed environment.
• Plan, implement, and oversee studies for quality process improvements and cost reduction. Using statistical methods; identify sources of quality problems and help design corrective action programs.
• Compile, extract, analyze data and draw conclusions to recommend actions for improvements.
• An ideal candidate will possess ability to define problems, establish facts, root causes, and corrective action, collect data and assist in developing valid conclusions.
• You should be able to interpret technical instructions (written or oral) in mathematical, verbal, or diagrammatic form.
• A minimum of a Bachelor’s Degree or equivalent degree is required.
• A minimum of 2 years of experience in a GMP and/or ISO regulated environment is required. Experience in the medical device and/or pharmaceutical industry is also required.
• Previous MDR experience is valuable.
• RAC or ASQ certifications highly preferred.
• The ability to work independently and prioritize with little supervision is required.
• Strong written and oral communication and interpersonal (listening) skills are critical for success.
• Must have an aptitude to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision-making.
• Analytical, Critical thinking, time management, and interpersonal skills are required.
• Compliance with US (FDA), and foreign (European – MDD, Canadian – CMDCAS, etc.) regulations and standards, including the Quality Manual, Operating Procedures, ISO 13485 and other standards as applicable are required.
• This position is located in Palm Beach Gardens, FL and may require up to 10% travel, including potential international.
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.
United States-Florida-Palm Beach Gardens-
Depuy Orthopaedics. Inc. (6029)