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