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Cork, IE

Staff Quality Systems Analytics Engineer-000009ZX

Description

POSITION: Staff Quality Systems Analytics Engineer

REPORTING TO: Global Orthopaedics Management Review Manager

LOCATION: DePuy Synthes

Role Overview

The Staff Quality Systems Analytics Engineer will establish and maintain strategies for analyzing internal and external data from various sources in order to ensure ongoing quality and regulatory compliance and drive continuous improvement in the company's Quality Management System and processes.

The Staff Quality Systems Analytics Engineer will support the development; execution and continued oversight of best in class Analytics strategies across the DePuy Synthes Franchises. This role will manage key Analytics programs such as the Global Dashboard, Q-Scan reporting, the EDGE corporate reporting system. This individual will have visibility to, and participate in sector and corporate wide Analytics initiatives.

Major Responsibilities

The Staff Quality Systems Analytics Engineer is accountable for the responsibilities below:
- Devise and implement methods and procedures for monitoring, control and evaluation of trend analysis within and across quality sub-systems data.
- Identify key sources of internal and external quality systems and regulatory compliance data.
- Provide analysis as inputs into Management Review.
- Improve, integrate & institutionalize DePuy Synthes quality systems metrics and analysis.
- Identify, mitigate and communicate quality risks through the use of analytic statistics to identify positive and adverse trends.
- Demonstrate knowledge of, and ability to, apply appropriate statistical techniques in support of this analysis.
- Lead Q-Scan data gathering process across Franchise as needed for MD&D sector.
- Provide applicable change management for the Leadership teams across the Franchise
- Identify and implement best practice quality system improvements aligned with applicable DePuy Synthes, MD&D and corporate initiatives.
- Establish quality system and compliance dashboard metrics, maintain dashboard, and provide the business with information necessary to improve performance against dashboard where necessary.
- Perform focused research and analysis on specific issues as required.
- Respond to ad-hoc requests for summary reports of data.
- Engage DePuy leadership and leverage expertise, talent, and resources across the franchise and business units to execute against business strategy.
- Support departmental and franchise objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.

Qualifications


JOB REQUIREMENTS:
- Education: A minimum of a Bachelors Degree is required, preferable in engineering, scientific or statistical discipline. Masters degree is preferred.
- Black Belt/Green Belt Process Excellence/ Six Sigma training is required; certification is preferred
- A minimum of four (4) years of professional work experience within a quality assurance or compliance environment is required. Experience working in a Medical Device manufacturing environment is preferred.
- Education or training in the use of Probabilities and Statistics is required
- Working knowledge of CRF Title 21 part 820, ISO 13485, and applicable Quality System regulations, standards and guidance documents
- The ability to apply appropriate Quality tools/ systems/ processes to meet department goals and objectives, inter-dependently partner with cross-functional teams, make effective oral and written presentations, prioritize and manage multiple projects consisting of varying degrees of complexity, and analyze complex problems and apply practical solutions is required.
- The ability to independently analyze data, identify trends, formulate and implement corrective action to improve overall quality systems compliance, effectiveness, and efficiency is required.
- Analytically strong with deep knowledge of how to achieve process improvements and the conversion of data into meaningful business information.
- Strong communication, organizational, negotiation and interpersonal skills are required.
- The ability to collaborate with all levels of management across multiple sites and functions is required.
- A strong understanding of quality, business and financial metrics is required.

This position will require up to 10% international and domestic travel, with higher peaks depending on business need, and can be located at any DePuy Synthes site.

Rev A Jan 2013

Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Depuy (Ireland) Limited (7386)
Travel:Yes, 10% of the time
Job Function: Quality (Eng)