Quality Engineering Leader
Our client, a global leader in the Medical Device industry, are looking to recruit a Quality Engineering Leader for their Cork plant on a permanent basis.
- Support quality improvement initiatives
- Review/analyse the effectiveness of Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
- Supports the development of quality engineering, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
- Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians)
- Lead/provide guidance to the Line Quality team on areas such as Conducting investigations, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Approve IQ, OQ, PQ, TMV or Software Validation
- Document, justify, review or analyse whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
Education, Experience and Skills:
- Bachelor Degree, preferably in Engineering or a related technical field.
- 5-8 years' industrial experience, of which 3+ years in a team leading role
- Experience working a regulated environment is required. Such experience within a FDA / ISO 13485 regulated environment would be preferred
- Demonstrated ability to successfully use, and coach others in the use of, recognized data analysis and problem solving methodologies is required (e.g. DMAIC, Six Sigma, etc.)
- Strong coaching, mentoring and team development skills are required
- Technical training and experience in using Statistical Techniques, Lean and/or Six Sigma methodologies is preferred (e.g. SPC, DOE, Reliability Analysis, etc.)
For further information on this Quality Engineering Leader please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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