Quality validation engineer

Orange Recruitment are sourcing Quality professional looking to make a meaningful impact within a forward thinking and regulated manufacturing environment.

We're seeking a proactive and detail-focused Quality Validation Engineer to join our clients growing team in supporting compliance, process validation, and continuous improvement in alignment with global quality standards.

Responsibilities Ensure the implementation, upkeep, and continual improvement of the company's Quality Management System in compliance with relevant ISO and MDR standards.

Lead and support validation activities (IQ / OQ / PQ) for new and existing processes, including protocol development, execution oversight, and data evaluation.

Coordinate and perform internal quality audits, helping to drive best practices and ensure audit readiness at all times.

Act as a critical support member during customer and regulatory audits, providing documentation and expert input as needed.

Collaborate with cross-functional teams in product development, including process trials and first production runs.

Investigate and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies.

Monitor supplier performance and initiate NCMRs and corrective actions as needed, preventing defects from reaching final product stage.

Compile, analyse, and report quality metrics to leadership and stakeholders, contributing to the continuous improvement strategy.

Assist in the creation and revision of Standard Operating Procedures (SOPs), work instructions, and quality documentation.

Requirements Degree-qualified in Engineering, Science, or a related technical discipline.

Minimum of 3 years' experience in a quality-focused role within a regulated manufacturing environment, ideally medical devices or life sciences.

Certified Internal Auditor (ISO 13485) with hands-on experience leading or participating in audits.

Solid working knowledge of equipment validation, risk-based approaches, and statistical analysis.

Strong understanding of non-conformance handling, CAPA processes, and change control.

Meticulous attention to detail with excellent problem-solving and documentation skills.

Ability to communicate clearly across functions and work effectively both independently and as part of a team.