Job Summary
The Quality Validation Engineer will be responsible for ensuring the implementation, upkeep, and continual improvement of a quality management system in compliance with relevant standards.
Key Responsibilities:
* 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 audits 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 corrective actions as needed, preventing defects from reaching final product stage.
* Compile, analyze, and report quality metrics to stakeholders, contributing to the continuous improvement strategy.
* Assist in creating and revising 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.
* 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.