Our client, a medical device company in Galway are currently looking to recruit a Document Control Administrator for their site.
Document Control System administration and management through processing of required changes as per the current system. Co-ordination of workflow and prioritization including capture of relevant metrics. Additionally, Quality systems support to Quality Engineering and assistance with appropriate continuous improvement activities.
During periods of absence, the Senior Quality Systems Engineer shall ensure that all the responsibilities of this position are appropriately assigned.
- Responsible for the Q Pulse record management system (the computerized quality system tracking tool). This includes development and improvement projects, as appropriate.
- Responsible for the document control system including co-ordination of DCR process and ongoing compliance.
- Will generate reports for data trending and analysis of the quality system (as required).
- Will handle all administrative activities to support Document Control and Quality Records Storage including trending reports and tracking activities to assure compliance and in line with identified timelines.
- May assist or perform internal audits and assist in preparation for external audits, as required.
- Other quality system projects as necessary.
- Certificate/Diploma in Quality Assurance or equivalent industrial experience within the medical device industry, of which at least two years must be within a quality assurance or related role.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate effectively with all levels of the company.
- Ability to meet deadlines.
- Good understanding of EN ISO 13485, MDSAP and FDA Requirements.
- Proficiency in use of desktop software applications such as MS Office
Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.
For further information on this Document Control Administrator in Galway please contact Clara Burke on 086-8168273/ firstname.lastname@example.org
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