Quality Operations Lead

Location: Westmeath (Site-Based)

Reporting to: Head of Operations

The Role

This is a dual-function, hands-on leadership role combining Quality and Operational responsibilities. You will take ownership of the QMS while actively supporting manufacturing activities to ensure efficient, compliant production.

Key Responsibilities Quality Management Systems & Compliance

• Lead and manage the company's QMS, ensuring compliance with ISO 13485, EU Medical Devices Directive, and 21 CFR Part 820
• Oversee core quality processes including CAPA, non conformances, complaints, change control, and supplier quality
• Ensure audit readiness and participate in internal, external, and regulatory audits
• Embed quality and regulatory requirements across all operational and development activities

Design Quality Assurance

• Provide quality leadership across new product development and lifecycle management
• Support design reviews, risk management, and product recertification activities
• Lead Design Verification & Validation (DV/V) planning and execution
• Review and approve design documentation, protocols, and reports
• Drive continuous improvement using pre market and post market data

Operational & Manufacturing Support

• Work closely with production teams in a hands on capacity
• Support resource planning, inventory oversight, and production scheduling
• Train and mentor staff on new processes and products
• Track and report key KPIs (e.g., throughput, OEE, cost per unit)
• Drive process improvements to enhance efficiency and product quality
• Support new product introductions and production readiness

Requirements

• Degree in Engineering, Science, Quality, or related field
• 3-5 years' experience in Quality Assurance within the medical device industry
• Strong knowledge of ISO 13485, EU MDR/MDD, and 21 CFR Part 820
• Experience in Design Assurance and product development quality
• Exposure to manufacturing or production environments
• Lead/Internal Auditor qualification desirable
• Strong communicator with excellent cross functional collaboration skills
• Self starter with the ability to thrive in a fast paced start up environment
• Proven problem solving and decision making capability

Key aspects of the role

• Be part of a high growth start up with strong ambition and vision
• Take on a high impact, hands on role with real ownership
• Work across both quality and operations, broadening your experience
• Opportunity to shape systems, processes, and culture from an early stage
• Collaborative, innovative, and agile working environment

For further details on this position, please contact or call Gillian on .