Bilingual Quality Engineer - Mandarin

Job Description

I have an excellent new role with a company in Cork who are seeking a Bilingual Quality engineer to join their growing team. This is a permanent role with a flexible hybrid working model.

This person will have minimum 2 years' experience working in a Quality role in an FDA environment and must be fluent in English and Mandarin. Previous experience working in the production of medical devices or pharmaceutical products would be preferred along with working knowledge of 21 CFR 820. An educational background in science or engineering essential.

Responsibilities:

• Perform ongoing review of complaint files to ensure FDA compliance.
• Compilation of complaints to identify and communicate trends to manufacturers and/or auditors.
• Provide quality control support in complaint investigations.
• Provide complaint coverage, as necessary.
• Filing MDR ensuring compliance with FDA.
• Cross-training on other customer facing activities within the organization.
• Ensure compliance policies and associated documents are reviewed on a regular basis.
• Ensure activities are captured correctly in the workflow system.
• Assist in the preparation of monthly metrics and reports as required by the business to monitor and cross-compare the quality systems of manufacturers.
• Keep the Quality Assurance Manager and team updated on issues and actions which impact the business.
• Product supplier onboarding support.
• Be flexible within the Quality function to meet the needs of the growing business.

If this role is of interest, please 'apply now' or contact me on 021 2300 300 or at

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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