Product Quality Analyst

Location: Santa Ana, California
Posted On: 3/20/2017
Job Code: 3097_PQA_CA
Job Description
• Previous medical device complaint handling experience is beneficial.
• It would be good if they have experience with explantable or IOL devices.

Core job functions
• Responsible for analyzing client’s Vision product complaints to determine potential regulatory reportability while maintaining the quality processes related to client’s Vision post-market product complaints.
• Manages individual complaints on various client’s Vision product lines, from opening to closing.
• Performs accurate and timely data entry in corporate complaint database.
• Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources.
• Communicates directly with client’s Vision customers regarding reported complaints and resolutions.
• Analyzes complaint data to identify any trends, and provides information to department management and other personnel that may lead to a Corrective Action Request.
• Works with other departments and vendors on known or emerging issues to resolve quality problems that may impact patient safety.
• Responds to technical or medical information requests from healthcare professionals, client’s Vision personnel and consumers.
• Assists global client’s Vision departments by providing ad-hoc reports related to product complaint trending and investigations.

• Analyzes and resolves client’s product customers technical and clinical questions regarding client’s products.
• Corresponds with customers regarding the results of inquiries and analysis of products Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints.
• Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues.
• This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints.
• Interfaces with all levels of health care professionals ( doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems.
• Communicates customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R & D engineers, business unit managers, and other personnel to communicate the findings.
• Performs product complaint documentation, investigation, customer response, and consulting activities on client’s products and authors correspondence to customers addressing complaint investigations.
• Serves as a liaison between other business units for quality and technical concerns as needed.
• Knowledge of Medical Terminology.
• Five - seven years of customer support experience preferred.
• Strong PC/Data Entry Skills required.
• A high degree of interpersonal relations skills.
• Strong verbal and written communication skills.

Problem Solving:
• Must be able to work under pressure and stress common to office environments.
• Must be able to maintain a high degree of accuracy and analytical thinking.
• Must be able to deal effectively with problems and customers on the telephone.
Category:IT  code:new
Job Requirements
complaint handling, customer complaint, complaint investigation, customers on the telephone, resolves customer complaints

Not Ready to Apply?
Contact Details
Nikunj Patel
E-mail Address