Quality Engineer

Customer Success          ·          Entry Level         ·          Remote         ·          Full Time

About the Job

The Quality Engineer will work closely with colleagues to support the following activities at Neuromod:

• Creation, review, and approval of QMS documentation.
• Process and product development activities (including validations).
• Execute troubleshooting and investigation activities.
• Risk assessment activities.
• Evaluation, approval, and management of vendor interactions relating to product quality.

Responsibilities and Essential Functions

• 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.

Education, Qualifications and Experience

• 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

For further information please contact Aoife McNally aoife.mcnally@neuromoddevices.com

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