Quality Validation Engineer

Job description

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.