Job Specification: Quality & Operational Improvement Lead

Location: Belfast, Northern Ireland
Employment Type: Full-time / Permanent
Salary: Competitive, based on experience

About Us:

We are a progressive and patient-focused male fertility laboratory operating under the highest international quality standards: ISO 13485 (medical devices) and ISO 15189 (medical laboratories). Our mission is to develop cutting edge male fertility diagnostic tools and deliver reliable diagnostic services with precision, compassion and operational excellence.

Role Summary:

We are seeking a highly motivated Quality & Operational Improvement Lead to support the continuous improvement of our well-established Quality Management System (QMS) and to lead enhancements across our operational processes. This role is ideally suited to a candidate with a scientific background and a proven track record in quality-focused roles, particularly within medical or laboratory environments.

You will be responsible for ensuring regulatory compliance, enhancing operational efficiency, and embedding a culture of continuous quality improvement. You will also support and coordinate activities related to data protection, risk management and contingency planning.

Key Responsibilities:

Quality & Compliance

• Oversee and administer the day-to-day operation of the QMS, ensuring compliance with ISO 13485 and ISO 15189.
• Prepare for and manage internal and external audits, inspections, and certification renewals.
• Lead document control, non-conformance tracking, CAPAs, and management reviews.
• Ensure all quality activities are aligned with patient safety, regulatory requirements, and best practices.

Operational Efficiency & Process Optimisation

• Lead efficiency and workflow improvement projects across the laboratory, focusing on LEAN principles and optimisation of lab operations.
• Collaborate with laboratory staff to analyse bottlenecks, streamline SOPs, and improve turnaround times and resource utilisation.
• Manage relationships with key suppliers, ensuring quality, reliability, and cost-effectiveness of goods and services.
• Track and report on quality performance of vendors and third-party service providers.

Data Protection, Risk Management, Business Continuity

• Support the organisation’s Data Protection Officer (DPO) by maintaining the data register and assisting with compliance efforts related to GDPR and other applicable data protection legislation
• Conduct regular risk assessments and support the organisation in implementing appropriate mitigations.
• Develop and maintain the organisation’s disaster recovery plan, aligned with business continuity goals and QMS requirements
• Support contingency planning for laboratory operations

Person Specification:

Essential Qualifications & Experience:

• A degree in a scientific discipline (e.g. Biomedical Science, Life Sciences, molecular biology) is preferred; however, candidates with relevant experience in other regulated environments working to ISO standards (e.g. ISO 9001, ISO 17025) will also be considered.
• Minimum of 2 years’ experience in a quality or regulatory compliance role within a clinical, laboratory, or similarly regulated setting.
• Solid knowledge of ISO 13485 and/or ISO 15189 standards.
• Hands-on experience with QMS principles, including document control, CAPA management, and audit preparation.
• Familiarity with data protection regulations (e.g. GDPR).

Desirable:

• Experience leading process improvement or LEAN projects.
• Experience supporting or conducting risk assessments.
• Prior experience interacting with regulatory bodies (e.g. UKAS, MHRA, notified bodies) during audits, inspections, or advisory processes
• Experience contributing to or managing elements of disaster recovery or business continuity planning within a regulated or clinical setting.

Skills & Competencies:

• Strong attention to detail and a proactive approach to compliance and improvement.
• Excellent communication skills and ability to engage cross-functional teams.
• Organised, analytical, and capable of managing multiple concurrent priorities.
• Strong IT literacy (MS Office, data management tools).

What We Offer:

• A collaborative and mission-driven team.
• Opportunity to shape the operational direction of a cutting-edge laboratory.
• Investment in your professional development and training.
• Competitive renumeration package.

To Apply:

Send your CV to info@examenlab.com