Ref No: SF17278
Co. Dublin, Ireland
Senior Quality Engineer (Operations) - Dublin North.
This position is being offered initially as a 12 months' fixed-term contract.
In this role you will be responsible for co-ordinating the necessary activities for ensuring the timely closure of internal/external quality issues/projects, and to co-ordinate/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 company-wide departments to ensure internal system compliance and customer specifications are achieved, and to coach and drive a culture of compliance and continuous improvement.
Core 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.
• Manage and drive quality projects in support of continuous improvement.
• Trending and track of quality data to support quality improvements across the business
• Reacting and ensuring the timely closure of day-to-day quality issues e.g. CAPA / deviations and change controls.
• Complete batch / sample inspections and documentation in line with batch manufacturing rules and GMP requirements
• Support incoming inspection and controls as per GMP requirements.
• Batch paperwork review and final decision to release product for shipment.
• Facilitate risk assessments as required to ensure continuing compliance, safety and quality of processes and products
• Interface with other departments with respect to sharing of best practices.
• Monthly reporting of key performance indicators (KPI’s) and co-ordinating necessary activities to drive improvements or address adverse trends.
• Management of customer documents into the Quality system i.e. drawings; purchase specification; quality agreements etc. and the training of relevant personnel.
• Drafting and approving of quality documentation to meet company and customer requirements i.e. Quality Specification Sheets (QSS), CAPA’s, deviations, defect library, raw material specification etc.
• Participate in the review of validation protocols and reports to ensure quality compliance.
• Executing internal and external process and system audits.
• 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.
• 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.
Interested applicants should have:
• 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 13485 / 21 CFR Part 820 is essential.
• Ideally will have experience of third party and regulatory 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.
• Auditing experience to the requirements of ISO 13485 / 21 CFR Part 820 is preferred. Auditing experience to 21 Part 820 / and EU GMP is considered an advantage.
• Ideally have an understanding of Environmental Management System ISO 14001.
• Ideally have a working knowledge of Lean / 6 Sigma tools. Green Belt certification in preferred.