Senior Quality Engineer – Cork
· Supervision, coaching and mentoring of Quality Technicians and Quality Engineers.
· Lead, in conjunction with production and engineering functional Seniors, a production core team to achieve plant targets across Quality, Service and Cost.
· Act as CAPA Mentor ensuring CAPAs identify root cause and effective solutions and are completed in compliance with regulatory and procedural requirements
· Ensure team is focused on appropriate trending, investigation, root causing and corrective action of non-conformances & customer complaints.
· Use problem solving expertise to drive root cause identification for process and product issues
· Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
· Approval of change requests for product, process and quality system changes.
· Identification & utilization of key quality metrics in areas of responsibility to identify improvement opportunities.
· Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).Drive and implement plant wide quality system improvements.
· Define process and product validation requirements. Validation protocols and reports approval.
· Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
· NFQ Level 8 in a relevant discipline.
· Minimum of 6-8 years’ experience in a similar industry.
· Good technical capabilities, communication skills, teamwork abilities and initiative.
· Proven ability to work well as part of a team & on own with minimum supervision
For a confidential discussion and more information on the role, please contact Lauren McCarthy.