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 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 gillian.nicholson@collinsmcnicholas.ie or call Gillian on 0906450665
