Description
I have an immediate opening for a Senior Quality Engineer with a rapidly growing medical device company based in Dublin. This is a permanent position with plenty of opportunity for career progression.Reporting to the Quality Engineering Manager this role is responsible for coordinating the necessary activities for ensuring the timely closure of internal/external quality issues / projects and to coordinate / drive continuous improvement initiatives including mentoring to the business with respect to the relevant quality tools. Central to this role will be the need to liaise with companywide departments to ensure internal system compliance and customer specifications are achieved and to coach and drive a culture of compliance and continuous improvement.
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.
* Must be able to prioritize and organise tasks.
* 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 e.g. 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 i.e. 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 i.e. Quality Specification Sheets (QSS), CAPA's, defect library etc.
* 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.
* Interface with other departments on a daily basis.
* Analysing and reporting of key measures eg. Ppk's, Cpk's, cost of quality, customer complaints, and internal/external quality results.
* Compliance to all local site company policies, procedures and corporate policies.
* Perform additional duties at the request of the direct supervisor.
* Lead and manage a high performing team to deliver the defined business goals and objectives.
* Act in accordance with the company's guiding principles and adherence to the corporate Code of Conduct.
* Identification and development of talent to include performance management and succession planning.
* Coaching / development of reports using development and retention plans as appropriate.
* Responsible for the identification and development of talent, to include performance management, coaching and mentoring for high performance.
If you are interested in hearing more about this excellent Senior position in Dublin, please apply directly to this advert or contact Derek Sheridan on for immediate consideration.