Senior Quality Engineer

Dublin  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

I have an immediate opening for a Senior Quality Engineer with a leading medical device company based in Dublin. This is a brilliant opportunity to join rapidly growing company in Dublin that offer fantastic opportunities in career development and progression.

Requirements:
* Must have a third level qualification in Engineering/Quality/Science.
* Must have a minimum of 5 years experience of working in a high volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector. A background in Drug Handling would be considered an advantage.
* A thorough working knowledge of quality systems such as ISO CFR Part 820 is essential. Knowledge of 21 CFR Part would be considered an advantage.
* Ideally would have experience of FDA audits and the preparation of same.
* Must have a thorough understanding of statistics, SPC, and ideally the use of Minitab.
* Must have an in-depth knowledge of validations in a Medical Device environment.
* Must have excellent communication skills both oral and written.
* Auditing experience to the requirements of ISO CFR Part 820 is preferred. Auditing experience to 21 Part 820 and / or 21 Part 211 is considered an advantage.
* Ideally have an understanding of Environmental Management System ISO 14001.

Essential Duties and Responsibilities:
* Interface with customers to ensure concerns/complaints are communicated and corrective actions are closed in a timely manner.
* Support new programs with respect to validation, data analysis and system implementation.
* Act as mentor to the business with respect to the use of Lean / 6 Sigma tools.
* Support internal audit function in order to monitor compliance / drive improvements.
* Reacting and ensuring the timely closure of day-to-day quality issues eg MRR / IPI/ CAPA and change Controls.
* Interface with other departments with respect to sharing of best practices.
* Monthly reporting of Key Performance Indicators (KPI's) and coordinating necessary activities to drive improvements or address adverse trends.
* Management of customer documents into the company Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
* Drafting and approving of quality documentation to meet the company and Customer requirements ie Quality Specification Sheets (QSS), CAPA's.

* Participate in the review of validation protocols and reports to ensure quality compliance.
* Executing internal and external process and system audits.
* Manage and drive quality projects in support of continuous improvement.
* Co-ordinate activities associated with change management and customer interaction.
* Analysing and reporting of key measures eg. Ppk's, Cpk's, Cost of Quality, Customer Complaints, and Internal/external quality results.

If you are interested in hearing more about this fantastic opportunity please respond with an updated CV or contact Derek Sheridan on for further information
Start date
09/2014
From
Real Staffing
Published at
22.11.2014
Project ID:
812279
Contract type
Permanent
To apply to this project you must log in.
Register