Quality Operations Lead

Co Westmeath
Permanent
Full-time

27 days ago

We are partnering with an innovative and rapidly scaling medical device company to recruit an Quality & Operations Lead This is a unique opportunity to join a dynamic start-up environment where you will play a pivotal, hands-on role in shaping both the Quality Management System (QMS) and manufacturing operations from the ground up.If you're looking for a position where you can make a real impact, work cross-functionally, and grow with an ambitious organisation, this could be the perfect next step in your career.Location: Westmeath (Site-Based)Reporting to: Head of OperationsThe RoleThis 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 ResponsibilitiesQuality 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 0906450665

Collins McNicholas

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