Senior Quality Engineer
Senior Quality Engineer with at least 10 years experience urgently required for a Permanent role in Medical Devices.
This Cork based opportunity will suit someone with CSV Validation experience and can offerexcellent career development within the expanding organisation.
Excellent role with leadership responsibility, please get in touch today.
- Leads and manages investigations to identify root causes, establishes corrective actions and executes prevention plans in products and/or processes
- Approves and defends corrective actions for deviations, provides formal structured approach to assist in determining root cause for nonconforming events and evaluate CAPAs for lifecycle effectiveness
- Reviews Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned
- Assure timely completion of CAPA items
- Proficient in process, product,and data review within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, material and technique-related issues
- Monitor the site specific indicators for CAPAs/Deviations/Complaints/Yield/CPP/CQA as appropriate and escalate potential outliers or negative trends to the appropriate areas as needed
- Works with the Supplier Management Organization to mine, analyze data and drive root cause analysis and corrective actions that will help eliminate supplier related quality issues
- Analyzes data/metrics using sound statistical practices. Develops and implements solutions based on statistical analysis
- CAPA management for the facility, criticality assessment of CAPA’s, and CAPA effectiveness
- Checks complaint investigations/evaluations for completeness. Supports the preparation of periodic reporting (daily, weekly, monthly, quarterly, annually).
- Researches and writes special investigations for trends. Reacts quickly to trends and issues detected by quality intelligence data and effectively addresses them.