Quality Engineer

Title: Quality Engineer
Location: The Digital Hub, Rainsford St, Dublin 8.
Benefits: Competitive salary, Health insurance and Hybrid working


Company:
My client are a Medical Device company who started up in 2010 and have developed and patented a bimodal neuromodulation technology that it is evaluating for neurological disorders. The lead application of this technology is through a device which has been shown to soothe and relieve tinnitus, a condition affecting 10% of the adult population and commonly known as 'ringing in the ears'.

Having launched in the States in April and received FDA approval this year also it is an exciting time to be part of this team.


Responsibilities:

• Work collaboratively with cross-functional teams (Engineering, Product Development, Operations etc) to improve existing products.
• Lead/participate in operational excellence and continuous improvement initiatives using recognised methodologies such as Six Sigma, Lean, Kaizen etc.
• Evaluate quality costs, determine critical causes, and identify and implement improvements.
• Develop and lead supplier process improvements that minimize production costs and defects.
  • Provide product and process DFM (Design for Manufacturing) input to Engineering to enhance manufacturability and improve product quality and cost.
  • Analyse data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
  • Evaluate Supplier quality trends and reasons for product or process failures relating to customer complaints and lead and support the rollout of corrective and preventive action plans.
  • Work directly with critical subcontractors (both virtually and through on-site visits) to ensure product quality, maintain compliance of product lines and to gain understanding of and assist in resolution of product quality issues.
    • Provide QE support for New Product Development (NPD) projects and design review activities.
    • Review product requirements, specifications, and technical design documents to provide timely and meaningful feedback.
    • Develop, monitor, and report on KPIs and quality objectives.
    • Any other reasonable duties as required.
    • Some travel will be required.

• Third level Engineering/Manufacturing/Science degree qualification or equivalent.
• 2+ years in regulated work environment (preferably in Medical Devices).
• Good working knowledge of ISO 13485.
• Understanding of MDR requirements.
• Understanding of CFR requirements.
• Internal/Lead Auditor training preferable