Reference: JOM AKWK-626560
Position: Quality Engineer
Location: Dun Laoghaire, Dublin
Main Responsibilities:
* Managing the activities of the Quality Inspectors to ensure optimal efficiency and compliance with all regulatory requirements.
* Drive root cause analysis of non-conformances with relevant personnel and ensure corrections are implemented before starting back to production after a quality issue.
* Drive and maintain cGMP practices across all operational departments under your quality responsibility (Incoming, assembly, packaging, warehouse) and attend departmental and other meetings as appropriate.
* Release batches in SAP from packaging to sterilization and final release. Complete DHR reviews and batch releases.
* Liaise with relevant personnel regarding flow of product through QC department and other issues that arise.
* Review, analyse and report on relevant customer complaints and institute corrective actions.
Experience:
* At least 3 years previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
* Degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
* Statistical Process Control.
* Six Sigma methodologies (Greenbelt Certification would be advantageous).
* CAPA system management.
* FDA requirements and managing FDA audits.
* Good knowledge of SAP and Trackwise.
* Continuous improvement projects e.g. Project Win SPC, automated machine.
* Process validation.
* Clean room environment.
* Cross-functional team experience.
* Excellent interpersonal and communication skills.
* High level of computer literacy.
Eligibility: Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.
Contact: Joan O’Malley at 087-1897333 for more details.
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