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Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at TN Ireland. As a Quality Assurance Specialist, you will be responsible for managing the quality function and providing work direction for quality engineers and inspectors.
You will interact regularly with engineering, manufacturing, and service functions to establish quality standards for raw material, work in process, and finished products.
- Develop and implement a strategy to foster a high performance culture with quality right first time suitable for a world-class medical device manufacturer.
- Lead and motivate a large team with strong quality assurance, quality control, stakeholder partnership, risk assessment, and mitigation. Benchmark and implement best practice.
- Drive improvements to the quality system that ensure its suitability, adequacy, and effectiveness.
- Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
The ideal candidate will have a Bachelor's degree in Engineering or a scientific related field, and a minimum of 4 years' experience in the medical device or pharmaceutical industry, with at least 3 years' experience in regulatory compliance and quality systems.
Able to effectively work with various functions and levels within the organization. Strong written and verbal communication skills; strong presentation skills.
