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Product Quality Analyst


This is a Contract position in San Fernando, CA posted October 30, 2019.

Product Quality Analyst 1 Year Contract Sylmar, CA Description: Analyzes and resolves Abbott product customers technical and clinical questions regarding Abbott 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 Abbott 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.

– 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.

Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry.

At least one year of experience with MDR and OUS regulatory reporting experience required.

Knowledge of the use, development, and regulatory environment of medical devices.

Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting.

Education: Four-year degree, preferably in the healthcare or science fields; or 2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.

Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.

Duties: May perform multiple functions within the postmarket surveillance department.

Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.

Complete FDA MDR and other outside competent authority regulatory reports.

Initiates and manages the complaint file, maintains accurate entry of complaints in the database, communicates to field representatives regarding information needed specific to product complaints (e.G.

physicians, hospital personnel, sales representatives, international offices).

Diligent of any unusual trends in product complaints and communicates them with mgmt., complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors.

Performs other related duties and responsibilities as assigned.

Experis is an Equal Opportunity Employer (EOE/AA)
– provided by Dice