Our client a global healthcare leader based here in Galway City are looking to hire an Associate Quality Engineer Customer Service on a fixed-term basis.
Customer Service ARDX works across all functions within the ARDX function to ensure that Customer orders are managed and processed at every stage of their journey. One of the key activities within CS is cross-alignment with the Quality and Compliance function in terms of Work Instructions, Quality Incidents (QI’s) and CAPA’s and adherence to our Quality Management system. it is a functional responsibility to investigate, document and manage all functional QI’s and CAPA’s in a timely manner.
- Cross alignment between the Customer Service functions (both International and Domestic) and the Quality function.
- Understands the Quality Management System (QMS) in place, Company Standard Operating Procedures (SOP’s) and Work Instructions (WI’s) and works in compliance with established procedures and/or protocols.
- Works with all CS staff and related departments to investigate QI’s and then prepares and manages all functional QI documentation in Agile in an accurate and timely manner, adhering to timelines for completion at each stage.
- Works with all CS staff and related departments to prepare and manage all functional CAPA’s documentation in Agile in an accurate and timely manner, adhering to timelines for completion at each stage.
- Drives alignment across related departments to receive accurate and timely input into all QI and CAPA actions.
- Management and support for any Field Safety notices that need to be issued to customers.
- Periodic Functional review of SOP’s, WI and Documentation and alignment with the Quality department to ensure these are done in alignment with policies, timelines and protocol.
- Represents Customer Service in all Continuous improvement meetings - Administration and support of the CAPA/ NC process through weekly continuous improvement meetings with Quality.
- Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems. Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
- Possesses and applies a fundamental and increasing knowledge of Quality, and its application within the company to the completion of routine assignments.
EDUCATION & COMPETENCIES
- Minimum 1 years’ experience in medical device industry.
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP).
- Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL).
- Experience in writing up Quality Incidents and CAPA’s in a concise and compliant format.
- Competency in conducting technical review of all documentation / communications.
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
- Previous experience with international order management or Subject matter expert on International Customer Service processes, procedures and exceptions is desirable.
For a confidential discussion and more information about the role please contact Michelle Mc Inenrey
091 706 717