St Andrews Medical Innovations develops and sells Arclight Project devices worldwide. Our flagship product, the Arclight ophthalmoscope-otoscope, has been sold in over 60 countries, with more than 50,000 devices in circulation, improving healthcare in low-resource settings and beyond.
We're at an exciting stage of growth and expansion, and are looking for a Quality & Operations Manager to plan, control and continuously improve all day-to-day operational activities. This is a fantastic opportunity to grow with the company and make a real impact in global healthcare.
Job Scope (Role and Responsibilities)
This role combines responsibility for maintaining and improving the company’s Quality Management System (QMS) with oversight of day-to-day operations, including inventory, order fulfilment, and warehouse management. The postholder will play a key role in ensuring that products are delivered efficiently, consistently, and to a high standard of quality, while supporting the continued growth of St Andrews Medical Innovations.
Key Responsibilities
Quality Management
* Lead the maintenance and continuous improvement of the ISO 13485 Quality Management System (QMS)
* Act as Management Representative, ensuring processes are documented, implemented, and effective
* Monitor QMS performance and report on effectiveness and areas for improvement
* Promote awareness of quality requirements across the organisation
* Manage document control systems, including SOPs, records, and change controls
* Support internal and external audits and ensure follow-up of actions
* Lead CAPA processes and continuous improvement initiatives
(Note: Experience with ISO 9001 or similar quality systems is highly relevant; ISO 13485 knowledge can be developed in post.)
Operations & Supply Chain Management
* Plan, manage, and continuously improve day-to-day operational activities including purchasing, inventory, logistics, and fulfilment
* Ensure products are delivered safely, on time, and to required quality standards
* Oversee supplier relationships, purchasing processes, and cost control
Warehouse & Inventory Management
* Oversee the management and organisation of the stock warehouse
* Maintain accurate, real-time inventory records (finished goods, components, consumables)
* Set and manage stock levels and reordering processes
* Implement and improve stock control systems and procedures
* Ensure appropriate storage conditions and product traceability
* Conduct regular stock audits and reconciliation
* Oversee order processing (web, bulk, and international orders)
* Manage picking, packing, and dispatch processes
* Coordinate shipping, couriers, and freight forwarders
* Ensure export documentation and shipment tracking are handled effectively
* Resolve delivery issues and maintain clear communication with customers
Quality in Operations
* Ensure labelling, packaging, and documentation meet internal quality standards
* Maintain device records, batch documentation, and traceability
* Support feedback and complaints handling processes
* Analyse operational data and KPIs to drive improvements
Job Requirements
Education & Qualifications
* Bachelor’s degree (or equivalent experience) in Life Sciences, Engineering, Supply Chain, Business, or a related field
* Training or certification in a Quality Management System (e.g. ISO 13485 or 9001) is desirable
Experience
* Experience in an operations, quality, or combined role within a structured or regulated environment
* Strong hands-on experience in operations, logistics, or supply chain management
* Practical experience with stock control and warehouse management
* Experience working with a Quality Management System (e.g. ISO 9001 or similar)
* Experience in SMEs, start-ups, or growing organisations is desirable
Knowledge & Skills
* Good understanding of quality management principles and continuous improvement
* Familiarity with ISO 9001 or similar standards (ISO 13485 desirable but not essential)
* Experience with ERP/MRP or inventory systems
* Strong organisational and problem-solving skills
* Ability to manage multiple priorities in a hands-on environment
* Clear written and verbal communication skills
Personal Attributes
* Proactive and adaptable, with a continuous improvement mindset
* Detail-oriented with strong organisational skills
* Comfortable working in a small, fast-moving team
* Practical and willing to take a hands-on approach when required
Interested?
Apply now and be part of a company making a difference in healthcare worldwide! Please send us your CV and a cover letter detailing why you would like to work for us and what makes you suitable for the role.
Further information and informal enquiries may be directed to Nicole Stewart, Finance & Operations, email: si-hr@st-andrews.ac.uk. Closing date for applications is Thursday 21st May 2026.
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