Job Overview:
We are seeking a Quality Assurance Specialist to play a critical role in supporting compliance, process validation, and continuous improvement within a regulated manufacturing environment.
The successful candidate will have a strong background in quality management systems, with experience in leading or participating in audits.
Key Responsibilities:
* Implement, maintain, and continually improve the company's Quality Management System to align with global quality standards.
* Lead and support validation activities for new and existing processes, including protocol development, execution oversight, and data evaluation.
* Coordinate internal quality audits and drive best practices to ensure audit readiness.
* Support customer and regulatory audits, providing documentation and expert input as needed.
* Collaborate with cross-functional teams in product development.
* Investigate and resolve non-conformances, deviations, and CAPAs through structured problem-solving methodologies.
* Monitor supplier performance and initiate corrective actions as needed.
* Compile, analyze, and report quality metrics to leadership and stakeholders.
Requirements:
* Degree-qualified in Engineering, Science, or a related technical discipline.
* Minimum 3 years' experience in a quality-focused role within a regulated manufacturing environment.
* Certified Internal Auditor (ISO) with hands-on experience leading or participating in audits.
* Solid working knowledge of equipment validation, risk-based approaches, and statistical analysis.
* Meticulous attention to detail with excellent problem-solving and documentation skills.