Senior Quality Engineer to play a pivotal role in site process improvement activities.
Senior Quality Engineer- Medical Device- Dublin
My client are looking for a Senior Quality Engineer to play a pivotal role in site process improvement activities. 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 & Shift Quality Engineering function. You will report to the Quality Operations Leader.
- 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;
- Any other reasonable duties which may be required by management from time to time.
Education and experience:
- You will have a bachelor's degree in a Science/Engineering discipline;
- A minimum of 5 years work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry;
- 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.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.