Quality Engineer

Job Title: Quality Engineer/programme manager

Location: Mansfield, MA
Duration: 12+Months (Possibility of extension)

Job Role:

·This position is probably most closely associated with a Quality Systems Manager (IT oriented), with good program management skills.

·We need a proven leader/strong personality that understands Quality Systems/Quality Compliance, processes, etc. and an ability to Deliver on Time.

·Person should come from a Med. Device background.

Position Summary:

·The PMV Data Manager is responsible for leading a group of PMV Data Analysts in developing statistically based ad hoc reports utilizing data generated by the Client complaint system to assist in the evaluation of safety triggers by PMV Analysts, providing leadership in the administration of the Client Complaint Tracking System (CTS) across the various Surgical Solutions Group sites, developing systems to provide support and tracking of ad hoc reporting outside the complaint group, as well as development and maintenance of the PMV SharePoint site.

·The PMV Data Manager must be highly motivated and able to produce results with little need for direction.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·Design, create and validate ad hoc reports regarding various aspects of complaint activities to a multitude of different departments located in different locations.

·Must be able to analyze the data and present it in a format suitable to the requestor, in most cases Excel.

·The information provided may be used in making business decisions, so accurate findings are imperative.

·Experience with designing and maintaining SharePoint sites.

·Information loaded to the site is used by the department as reference material, so up-to-date data is essential.

·Lead a group of PMV Data Analysts in the administration of the Client Complaint Tracking System including:

1.Maintainance of the replicated server in accordance with FDA regulations and corporate Quality Policy

2.Perform administrative functions in support of the complaint handling processes (i.e. user access, field modifications)

3.Suggest and implement system improvements based on user requests

·Provide training on the Client Complaint Tracking System

·Be able to develop relevant statistical methodologies for detecting event triggers.

·Generate queries, charts and perform analysis of complaint data in support of:

1.Monthly metrics

2.Corporate metrics

3.Product Quality Improvement Teams

4.CAPA metrics

·Support integration activities new sites onto the Client Complaint Tracking System.

JOB QUALIFICATIONS:

·Advanced knowledge of medical device use

·Strong knowledge of quality control concepts

·Self-starter with proven ability to successfully work with minimal supervision

·Proven ability to manage direct reports

·Excellent presentation and customer service skills

·Strong analytical skills including trend and statistical analysis

·Detail oriented and highly organized

·Demonstrated ability to communicate clearly both verbally and in writing

·Proficiency in Excel and Access databases.

·Understanding of relational databases.

EDUCATION:

·Minimum Bachelor’s Degree.

·Preferred Bachelor’s Degree in Science related discipline.

EXPERIENCE:

·Minimum 5 years related Post Market Surveillance and/or Quality Engineering experience with at least two years’ experience managing direct reports