Our client, a medical device company in Galway is currently looking to recruit a Associate Quality Engineer – International Customer Service for their site.
Reports to: Senior Customer Service Manager
Throughout 2018 and 2019, as the ARDX function and new BU structure evolves and develops, the operational scope of the Customer Service (CS) Function is also evolving and changing. In order to support these changing requirements and be able to facilitate the various goals, projects and other initiatives requested from CS – a new team structure is required! This new structure sets out to divide our activities better, so that we can separate out planning, performance evaluation and change management from that of Operational activities. In turn it will allow the teams to focus on prioritisation, strategic thinking and allow us to adapt quicker to a changing environment.
One of the key activities for this new structure is to have far better cross-alignment with the Quality and Compliance function. This past year has seen an increasing number of Quality Incidents (QI’s) and Capa’s and it is a functional responsibility to investigate, document and manage all functional QI’s and Capa’s in a timely manner. However we are seeing gaps evolve in this process, as a significant amount of QI’s and CAPA’s are being rejected by the Quality department as they are not written in line with Quality expectations. These rejections are only compounding the amount of work necessary for Quality, so we need to manage more effectively moving forward. To address this, we have identified that we are missing a qualified Quality engineer skillset with the Customer Service function – so this appointment will be to expressly address that.
Responsibilities and Duties:
- 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 prepares 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 Abbott to the completion of routine assignments..
- 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 further information on the Associate Quality Engineer role in Galway please contact Orla on 086 0449476/ Talent@hero.ie
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