Collins McNicholas

Description: This person will be working in the manufacturing area providing real time QA Support to the Production Line. This will include the implementation of process controls, CAPA systems, and day to day problem solving. This person will also be required to carry out process audits

Roles & Responsibilities:

    • Provide hands on line support to the mid-shift catheter and balloon production lines acting as a key member of the Line support team

    • Work with the senior QE to actively implement the same LMS systems and methodologies as on the day shift.

    • Ensure effective and efficient line handover from Day-Mid-Day shifts

    • Direct Involvement in continuous improvement projects and initiatives

    • Maintenance of quality metrics and reporting systems.

    • Preparation of Quality reports for Quality meetings and management reviews

    • Provide support to the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements

    • Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

    • Ensure regulatory compliance to GMP for all medical device regulatory agencies

    • Suggest changes in procedures and standards to facilitate work efficiency and maintain quality.

    • Reporting Functional area Quality Metrics

    • Conduct internal quality audits to ISO and GMP requirements

Requirements:

  • Min 4year industry experience in a medical device manufacturing environment and within a QA Role.

  • Science/ Engineering/Quality Degree and relevant experience

  • Experience within a hands on line support type role is highly desirable.

  • Excellent Computer Skills (word, excel, PowerPoint and Access)

  • Excellent communication (both verbal and written) & interpersonal skills

Please apply to Edyta Fleming on 091706721 or email edyta.fleming@collinsmcnicholas.ie.

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