Quality Technician

About Your New Employer :

This employer is a global leader in custom thermoformed healthcare packaging for medical devices and pharmaceutical industries.

The company has a strong 30 years old presence in Galway and is still expanding, presenting some exciting opportunities.

About Your New Job as a Quality Technician :

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.

What Skills You Need to succeed as a Quality Technician :

Bachelor's Degree in science, Quality, Engineering, Manufacturing or related field experience

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

What's on Offer for Candidates for a Quality Technician :

Salary of 38k - 45k DOE

Benefits package

Fantastic development opportunities

Working along successful team

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