FIELD ASSURANCE ENGINEER, CRANSTON, RI

Scope of the Job:

This position is responsible for providing assistance relative to the Manager, Field Assurance & Quality in handling customer complaints in compliance with divisional procedures, Corporate Guidelines and Federal Regulations.

Responsibilities:

· Functioning as a primary contact for Customers and Sales Representatives registering product complaints and treats all information received as confidential.

· Receiving and answering customer complaints on products.

· Assists with documenting and entering all complaints received in the Complaint Computer System assuring accurate completion of appropriate forms is completed.

· Preparing preliminary and detailed trend analysis.

· Compiling complaint acknowledgement letters to the customer as appropriate.

· Functioning as an internal contact between Field Assurance and Customer Service Department. Collaborates with Customer Service Department and shipping to ensure customer needs are fulfilled.

· Initiating contact with Customer, Sales Representatives and other Divisions regarding complaint information and the return of product for evaluation that has not been received as originally noted.

· Following-up on outstanding complaints sent to evaluators and reviews returned evaluation forms for completeness and accuracy and entering results of investigation and replacements into complaint software system and closes out the complaint.

· Serving as back-up to Manager, Field Assurance in manager's absence.

· Using product knowledge to evaluate potential product complain trends on a daily basis and informing the Manager, Field Assurance if a trend is developing.

· Preparing MDR and Vigilance determinations and the reporting of such.

· Assisting the Manager, Field Assurance in compiling monthly reports and special reports utilizing summaries from the Corporate Complain Computer system including guidelines regarding trends and corrective actions for Monthly Complain Review Meeting.

· May supervise Customer Complaint Handling employees.

· Special projects as assigned.

Candidate Requirements:

· Bachelor's Degree required in Engineering or Science.

· Extremely articulate in oral and written communications. Good interpersonal skills including ability to interact with high degree of diplomacy.

· Solid computer skills to include Word, Excel, Quality Analysis tools (Pareto, Histograms, etc. and database management.

· Three to five years experience in Complaint Handling MDR in medical device environment.

· Experience with bio-hazard management/contamination control preferred.

· Ability to handle multiple tasks in an organized/efficient manner and maintain good composure in stressful situations.

· Knowledge of MFG/Pro inventory management system desired.

· Some travel may be required.

Compensation:

A compensation package will be designed to attract outstanding talent and will include a base salary and an attractive benefits package.