Job Description

About Us

We are a dynamic and growing manufacturing business specialising in high-quality, regulated Lateral Flow Diagnostic (LFD) products. Operating under ISO 13485:2016, we are committed to excellence in every part of our operation--from Technical Transfer to production and distribution. With a strong customer focus and a collaborative team culture, we are now seeking a detail-oriented and proactive individual to strengthen our validation and quality functions across the business.

The Role

We are looking for a hands-on

Quality and Validation Lead

who will take ownership of validation activities and drive continuous improvement within our Quality Management System (QMS). This pivotal role ensures that our manufacturing processes, equipment, and systems are validated, compliant, and capable of consistently delivering safe, effective, and high-quality products.

You'll work cross-functionally with Technical, Manufacturing, and Operational teams to ensure that validation and quality standards are upheld across new product introductions, process changes, and ongoing production. This role also provides leadership in quality management, supporting audits, and QMS development.

Key Responsibilities

Validation Management:

Plan, execute, and maintain validation protocols and reports for equipment, processes, methods, and systems in compliance with ISO 13485:2016, and our internal QMS.

Quality Leadership:

Manage and maintain core elements of the QMS, ensuring compliance across manufacturing and operational activities.

Process & Equipment Qualification:

Lead IQ/OQ/PQ activities, ensuring robust processes and well-documented validation evidence.

Audit Support:

Prepare for and actively support internal and external audits and inspections.

Documentation Control:

Develop, review, and maintain validation and quality documentation, including SOPs, protocols, risk assessments, and reports.

Training & Knowledge Transfer:

Deliver training to manufacturing and quality teams to embed compliance and validation best practices.

Continuous Improvement:

Identify, assess, and implement improvements to validation practices and quality systems to enhance efficiency and scalability.

Cross-Functional Collaboration:

Work closely with Technical, Manufacturing, and Operations to ensure validation and quality considerations are integrated early into projects and sustained through commercial production.

What We're Looking For

Strong organisational skills with high attention to detail and documentation accuracy. Practical problem-solver with a continuous improvement and risk-based mindset. Experience in validation engineering, process/equipment qualification, or quality management in a regulated manufacturing environment. In-depth knowledge of ISO 13485:2016 standards and requirements. Familiarity with IQ/OQ/PQ protocols, validation lifecycle management, and quality systems. Excellent interpersonal and communication skills, with the ability to work collaboratively across functions. A proactive self-starter comfortable in a small, fast-moving team environment.

Why Join Us?

Play a critical role in ensuring the safety, quality, and compliance of life-enhancing products. Gain exposure to a wide range of operations within a regulated and innovative business. Be part of a close-knit, friendly team where your contributions make a visible impact. Shape validation and quality practices that support growth, scalability, and operational excellence.
Job Types: Full-time, Permanent

Pay: 40,000.00-45,000.00 per year

Work Location: In person