Job Opportunity
This position involves contributing to the development and implementation of a Quality Management System in compliance with relevant ISO and MDR standards.
Main Responsibilities:
* Develop, maintain, and improve processes ensuring adherence to quality management principles.
* Lead validation activities (IQ/OQ/PQ) for new and existing processes, including protocol creation, oversight, and data analysis.
* Coordinate internal audits, promoting best practices and audit readiness at all times.
* Support customer and regulatory audits by providing documentation and expert insights as needed.
* Collaborate with cross-functional teams on product development, including process trials and first production runs.
* Analyze and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies.
* Monitor supplier performance and initiate corrective actions to prevent defects from reaching final products.
* Compile, analyze, and report quality metrics to stakeholders, driving continuous improvement strategies.
Required Expertise:
* Degree-qualified in Engineering, Science, or a related technical field.
* Minimum 3 years' experience in quality-focused roles within regulated manufacturing environments, preferably medical devices or life sciences.
* Certified Internal Auditor (ISO 13485) with hands-on experience leading or participating in audits.
* Strong understanding of equipment validation, risk-based approaches, and statistical analysis.
* Familiarity with non-conformance handling, CAPA processes, and change control.
* Meticulous attention to detail with excellent problem-solving and documentation skills.
* Effective communication across functions and ability to work independently or as part of a team.