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Experienced Quality Assurance Specialist
2 months ago
Job Summary:
We are seeking a highly skilled Quality Engineer to join our client's growing operation in the Medical Device industry. As a Quality Engineer, you will play a crucial role in ensuring regulatory compliance and quality standards are met.
Key Responsibilities:
- Collaborate with the Head of Quality Assurance and manufacturing associates to ensure compliance with regulatory and customer requirements.
- Monitor and analyze critical to quality features in production, identifying trends and providing early warnings of potential quality issues.
- Maintain adherence to internal quality management system procedures and processes, in line with ISO 13485 and the Medical Device Directive 93/42/EEC.
Requirements:
- Previous experience in a quality-related field within a Medical Device design environment or a similar regulatory-controlled setting.
- Comprehensive knowledge and understanding of quality standards such as ISO 9001 and ISO 13485.
- Proficiency in quality and business management systems.
- Strong background in quality inspection and implementation of corrective action programs.
- Experience with product or industry-specific quality requirements.
- Solid computer skills and familiarity with quality tools, concepts, and methodologies.
- In-depth knowledge of applicable regulatory requirements, including Medical Device Directive 43/92/EEC.
- Proficient in continuous improvement techniques, procedure and report writing.
About the Company:
Our client is a prominent Medical Device company that values quality and regulatory compliance. As a Quality Engineer, you will have the opportunity to make a real impact and contribute to the success of the company.
