Description
I have an excellent opening for a Senior Quality Engineer with a leading medical device company based in Dublin.The Senior Quality Engineer will play a pivotal role in site process improvement activities. Reporting to the Quality Engineering Manager, duties will include management and approval of process validation studies, active participation in non conformance investigations and leading process improvement projects.
The role also involves the management of continuous improvement projects, application of SPC to current production processes, liaison with key customers and supervision of the QA/QC laboratories.
Responsibilities:
- Coordinating the activities of the Quality resources allocated to the Incoming, Packaging, Warehouse and Sterilization departments to ensure optimal efficiency and compliance with all regulatory requirements.
- Drive and maintain cGMP practice within the departments under your quality responsibility.
- Drive root cause analysis of non conformances with the department subject matter experts.
- Preparation, review and approval of technical documentation.
- Ensure all CAPAs under your responsibility are completed in compliance with all regulatory and procedural commitments.
- Become an active member of the site internal audit team, liaising with Regulatory auditors.
- Devise and implement Six Sigma continuous improvement projects.
- Act as customer liaison contact for given key customers.
- Review, analyse and report on relevant customer complaints.
- Support and drive key changes and improvements in manufacturing relating to product quality.
- Carry out Quality and Regulatory Compliance functions within the Quality Engineering Team
Relevant Experience:
- A minimum of 5 years work experience in an ISO or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
- Third level qualification in a Science/Engineering discipline
- Experience in the preparation of Technical Documentation.
- At least 3 years supervisory experience.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
- Experience in CAPA system management.
- A working knowledge of FDA requirements and managing FDA audits.
- Experience in process validation, Sterilisation and working in a clean room environment would be advantageous.
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.
If you are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on for further information.