careers / Quality Systems Administrator
Quality Systems Administrator
We are an Irish company that have devoted the past 30 years to delivering innovative custom automation, build to print and tooling solutions for the world’s most advanced manufacturers. Consecutively chosen as a Best Managed Company in Ireland by Deloitte for the past seven years, we are committed to always, always delivering the right solution. We specialise in designing and building bespoke, reliable, complete solutions which automate highly complex production processes. Through deep client collaboration we support our customers on the automation journey as they transition to smart methods of manufacturing that ultimately drive productivity and business efficiencies.
The Quality Systems Administrator will be responsible for the effective administration of Quality Management System activities including Document Control, Self-Inspections, Change Control, Deviations, CAPA, Training and Complaints in a fast-paced, dynamic, and high technology Automation company working with customers in a FDA regulated manufacturing sector.
This is a Permanent position operating in the Quality Department and reporting to the Quality & Validation Manager.
The role of the Quality Systems Administrator is to coordinate and manage the site EQMS including Document Control activities, preparation of quality trend data and taking appropriate action; supporting projects on all quality related issues; coordinating investigations of customer complaints/deviations and ensuring an effective and robust quality system which complies with all relevant regulatory requirements. The Quality Systems administrator will also be involved in continuous improvement programs across Departments as required.
This role requires an understanding of Quality Management Systems, the principles of Document Control, QMS Process Optimization and the ability to conduct QMS self-inspections to ensure compliance to regulatory, customer and internal organizational requirements.
- Minimum of 2+ years’ experience in QA/Compliance in a regulated environment.
- A third level Degree in a related Science or Quality Management discipline.
- Internal/Vendor Audit Accreditation would be preferrable.
- Responsible for day-to-day activities designed to maintain and enhance the local Quality Management System in line with ISO9001.
- Act as the primary Document Controller for the Business through the site EQMS.
- Key point of contact for all local documentation procedures and initiatives.
- Support the continuous improvement of the QMS including the development and implementation of improved quality reporting measures.
- Effective management and coordination of Quality Management Systems including change control, Deviations, CAPA, Training and Calibration data.
- Processing any quality related customer complaints, where necessary liaising with other Departments to close complaints.
- Support for QMS process optimisation and writing SOPs, Work Instructions, Policies etc. as required.
- Maintain quality associated training requirements.
- Compile Quality Systems data and metrics for all metric review meetings.
- Participate in investigations and corrective action implementation for identified quality issues including internal/external audits actions.
- Conduct QMS self-inspections to ensure compliance to regulatory, customer and internal organisational requirements.
- Support the Quality Manager in the preparation and hosting of the annual ISO9001 accreditation audit program.
- Assists in creating a culture of quality awareness and communicating the quality management system, and associated documents and procedures to all staff.
Key Skills & Attributes:
- Strong document control bias
- Strong knowledge of the ISO 9001 Directive
- Attention to detail
- Systems and Process thinking
- Enthusiasm for collaboration across Departments
- Good written communication skills
- Preference for a structured approach to working
- Time management
- Internal and External Customer focused
- Experienced in leading and supporting internal and external Audit programs.
- Knowledge of 21CFR Part 11 and ISO 13485 requirements, would be an advantage.
To apply, please send your Cover Letter and CV to firstname.lastname@example.org
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