A fantastic Quality team lead position with a Global provider of Medical Technologies based in Limerick
I am lucky to be working with a leading manufacturer of bespoke medical components and medical devices who are based in Limerick. This is a Quality leadership role heading up one of their value streams. The role will have on average 5 direct reports so someone who is comfortable in a people management role and works well cross functionally would be well suited to this position. Customer relationships (building, maintaining and influencing) will be a key element of this role.
- Owns all quality aspects of system, product and process, development, production, release and postproduction feedback.
- Responsible for ensuring that risks are identified, assessed, actioned, documented and maintained for the process/product through the entire supply chain of area of responsibility.
- Quality lead on all related product, process and test validation during design, development, transfer, and sustaining and change management phases of the lifecycle. Lead or support complaint evaluations and Customer interactions on high profile/complex situations to manage risk to the Patient, Customer and the business.
- Lead multi/cross functional project teams to drive process/system improvement and achieve milestones and results.
- Owns and drives the Safety/Quality/Service/Cost Metric for the assigned area.
- Excel in the technical competence required for the role, GMP's, QSR's, process validation, Statistical techniques, process monitoring and control tools e.g. SPC.
- Is committed to develop, coach, motivate self and team and supports development and growth of direct reports.
- Proactively engages in new product development to ensure a smooth transition from development to production.
- Ensure full compliance with regulatory requirements.
- Ensure Quality and EHS policies and procedures are adhered to at all times.
- Degree in an engineering/ quality related discipline
- 6+ years quality technical experience in a similar environment
- Certified Quality Auditor, preferred
- Technical report writing
- Process validations/risk analysis tools e.g. FMEA's
- Statistical analysis and Statistical Process Control
- Understanding of Lean Principles
- Project Management
- Working knowledge of ISO 13485 principles of GMP and FDA QSR 21 CFR Part 820 required
If you would like to hear more about this opportunity then give Kellie a call on 021 2300 300 or submit your application today and I will be in touch.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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