Job ID: JOB-13320
IS Engineer Lead
My client a medical device company is looking for an experienced IS Lead with strong Project Management skills to join their team onsite in Galway.
As IS Engineering Lead, this person will have responsibility for coordinating, overseeing, and controlling the work activities of the the IS Department to ensure alignment with the future corporate IT/IS strategic plan. In this role you will have responsibility for reviewing, evaluating, designing, developing and implementing an advanced and compliant ERP system solution to support the evolving business. Throughout the duration of ERP Systems investigative work, you will ensure that the current system is fully maintained and developed to meet internal customer requirements. Based on having established an, you will lead and showcase the IS Function and provide broad visibility of project delivery. appropriate ERP system, you will design a master project onload plan and project-manage all activities through to full implementation of the new ERP system. Working closely with the IS Team and Management
- To scope out key IS design/development projects based on Function demands and alignment with ERP strategy.
- To co-ordinate/make essential program changes to the Database System in line with specified business demands.
- To manage the integration of new systems (off the shelf/custom designed ) with the database System.
- To oversee the maintenance of the Database System and provide support to users throughout the business.
- To evaluate off-the-shelf ERP systems and select an appropriate ERP system that best fits future business position.
- To enable full system regulatory compliance based on system software regulations ( ref: FDA, BSI standards ).
- To project-manage systems design/development activities ( new application introductions etc ) to agreed project timelines
- To maximize systems, support resources through efficient work distribution, co-ordination and communications.
- To broaden communications with systems development management within the corporation.
- To interface with the appropriate hardware support providers to troubleshoot and resolve systems issues.
- To develop and document training manuals for IS systems. To deliver training to appropriate personnel when required.
- To lead the IS team effectively and provide essential people management support where required.
- To co-ordinate, in conjunction with validation engineering, the validation of new applications to satisfy regulatory standards.
Knowledge and Skills Required:
- Demonstrable Knowledge of medical device quality systems and ISO13485.
- An ability in number orientation (abilities in Mathematics; Accounting; statistics; and/or Finance)
- Strong computer programming Skills in Visual Basic for Applications (VBA) and T-SQL (Sql Server).
- Excellent Computer Skills (word, excel, PowerPoint and Access).
- Excellent communication (both verbal and written) & interpersonal skills.
- An analytical approach to problem solving.
- A self-starter that applies their own initiative in most situations.
- A team player, who works well in a smart team environment, must be able to work effectively with peers in other departments.
- A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
- Requires a Level 8 or higher degree in an IT/IS design and Development
- 8 years relevant experience in design/development and implementation of impactful ERP Systems.
- Recent experience with FDA GMP requirements is highly desirable.
For further information on this IS Manager role in Galway please contact Dee Curley on 086 7902191 / email@example.com
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Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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