Quality Assurance Specialist
2 days ago
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.
- 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.
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