Quality Technician II

1 week ago

Galway, Galway, Ireland Nelipak Healthcare Packaging Ireland Limited Full time

Role Summary: The Quality Technician II plays a crucial role in ensuring that products adhere to the necessary quality standards and regulatory requirements. Key Responsibilities: Support the implementation, maintenance, and continuous improvement of the QMS to ensure compliance with ISO 13485 standards. Perform regular QMS audits and participate in external audits to ensure adherence to regulatory requirements. Identify non-conformities, support root cause analysis, and drive corrective and preventive actions (CAPA). Maintain the document control system, ensuring timely review, approval, and distribution of quality documents. Ensure document changes are correctly implemented and version-controlled by company procedures. Assist in creating, revising, and controlling quality manuals, procedures, work instructions, and forms. Prepare reports and track findings through closure, ensuring corrective actions are effectively implemented. Assist in developing and delivering training programs related to quality system processes and regulatory compliance. Provide day-to-day support to staff on QMS processes and requirements. Assist with supplier qualification and monitoring processes, including supplier audits and performance evaluations. Ensure supplier documentation complies with regulatory and company standards. Respond to customer queries and provide documentation to support regulatory or quality-related requests. Participate in risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments. Monitor, document, and resolve non-conformances, deviations, and complaints. Track CAPA implementation to ensure timely and effective resolution. Qualifications & Experience: Bachelors Degree in science, Quality, Engineering, Manufacturing or related field experience The successful candidate will possess the following key attributes: Must have excellent MS Excel skills and be proficient in Microsoft Office Strong attention to detail Strong verbal and written communication skills. Understanding/awareness of Customer requirements in terms of quality and delivery. Ability to impart knowledge in a clear concise manner. Demonstrate working as part of a team with common goals. Take ownership of behaviour and workmanship. Decision-making and Reporting skills Skills: Quality System Quality auditing QMS Internal Auditing Dimensional analysis Benefits: Flexitime Group Life Assurance Paid Holidays Parking Pension Fund

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