Role Profile
Position: Operations & Quality Lead
Reporting to: Head of Operations
Department: Quality & Operations
This is a hands-on, floor-based leadership role within a start-up medical device manufacturing environment. The Quality & Operations Lead will play a critical role in building, implementing, and maintaining the Quality Management System (QMS) while actively supporting day-to-day manufacturing operations.
The successful candidate will come from a manufacturing/operations background within medical devices, with the ability to work directly on the production floor, managing incoming products, setting up equipment, performing validation and testing activities, and ensuring operational readiness.
This role requires someone who can bridge quality and operations, taking ownership of QMS development, compliance, CAPAs, and audit readiness, while also driving efficient manufacturing execution, inventory management, and lead time control.
Key Responsibilities
Quality Management Systems & Compliance
- Lead the development, implementation, and ongoing management of the QMS in line with ISO 13485, EU MDR, and 21 CFR Part 820.
- Build and maintain core quality systems including:
- CAPA management
- Document control
- Non-conformance & deviation management
- Change control
- Complaint handling
- Supplier quality
- Ensure the organisation is audit-ready at all times and lead/support:
- Internal audits
- External and notified body audits
- Regulatory inspections
- Drive a culture of quality across both development and manufacturing.
Operations & Manufacturing Support
- Work directly on the manufacturing floor to support daily operations.
- Manage incoming products and materials, ensuring readiness for production.
- Coordinate and oversee:
- Equipment ordering and setup
- Commissioning and validation of equipment and processes
- Perform and support:
- Process validation activities (IQ/OQ/PQ)
- Product testing and inspection activities
- Own inventory management and material planning, ensuring:
- Accurate stock control
- Optimised lead times
- Support production scheduling and resource allocation.
- Drive continuous improvement initiatives across manufacturing processes.
Design & Manufacturing Quality
- Provide quality oversight across product design and manufacturing transfer.
- Support design for manufacturability (DFM) and scale-up activities.
- Lead and support:
- Design Verification & Validation (DV&V)
- Risk management activities (e.g. FMEA)
- Ensure all design and manufacturing documentation meets regulatory and quality standards.
Startup & System Build
- Play a key role in building quality and operational systems from the ground up.
- Establish scalable processes for:
- QMS structure
- Manufacturing workflows
- Documentation systems
- Work cross-functionally to support rapid but compliant growth of the business.
Person Profile
- Degree in Engineering, Science, Quality, or a related discipline.
- 3–5+ years’ experience in a medical device manufacturing environment, with a strong blend of quality and operations exposure.
- Proven experience:
- Working hands-on in manufacturing/production environments
- Building or significantly improving a QMS system
- Managing CAPAs, document control, and audit readiness
- Strong working knowledge of:
- ISO 13485
- EU MDR / Medical Devices Directive
- 21 CFR Part 820
- Experience with:
- Process validation (IQ/OQ/PQ)
- Equipment setup and manufacturing scale-up
- Inventory management and lead time control
- Excellent communication skills with the ability to work cross-functionally.
For further details on this position, please contact gillian.nicholson@collinsmcnicholas.ie or call Gillian Nicholson on 0906450665
