Description
I have an immediate opening for a Senior Quality Engineer with our client, a global contract manufacturer serving the pharmaceutical and medical device industries that are based in Dublin.This role will involve coordinating activities and ensuring the closure of internal and external quality issues. Candidates with good experience in customer facing, dealing with customer issues and ability to meet deadlines are highly desired.
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 and coordinating necessary activities to drive improvements or address adverse trends.
* Management of customer documents into the Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
* Drafting and approving of quality documentation to meet company and Customer requirements ie Quality Specification Sheets (QSS), CAPA's, Defect Library etc.
* Executing internal and external process and system audits.
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 or Moulding 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.
* Must be able to prioritize and organise tasks.
* Ideally have an understanding of Environmental Management System ISO 14001.
If you are interested in hearing more about this role please apply directly or contact Derek Sheridan on for further information.
To find out more about Real please visit www.realstaffing.com