Quality Control Manager - County Longford.
In this role you will manage the quality function by providing work direction for quality engineers and inspectors, and interact regularly with engineering, manufacturing, and service functions to establish quality standards for raw materials, work in process, and finished products.
Key Responsibilities:
• Formulate a strategy to foster a high-performance culture with quality right first time.
• Coach and develop staff who support the quality function during the manufacturing process and drive a culture of quality awareness.
• Drive improvements to the quality system that ensures its suitability, adequacy, and effectiveness.
• Understand and ensure compliance with cGMP, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Work closely with commercial and operations to build value with key accounts and engage with customer quality representatives directly to implement short, medium, and long-term innovation and improvement plans.
Qualifications and experience requirements:
• Bachelor’s degree in Engineering or a scientific related field.
• 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.
• At least 4 years' experience in managing a team.
• Thorough knowledge of ISO 13485 and 21CFR Part 820.
• Strong written and verbal communication skills alongside strong presentation skills, with the ability to effectively work with various functions and levels within the organisation.
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