Shift Quality Engineer
A leading medical device client are now looking for an experienced Shift Quality Engineer to join their Dun Laoghaire team.
Reporting to the Quality Operations Leader, duties will include active participation in non-conformance investigations and lot disposition decisions, application of SPC to current production processes and liaison with key customer
The role also involves the supervision of QA/QC laboratories, approving of process validation studies, management of justified complaints investigations, and participation in change control processes and in process related adjustments and leading or participating in process improvement projects. You will prepare, review and approve technical documentation. You will become an active member of the site internal audit team, liaising with Regulatory auditors, perform audits and write reports.
As Shift Quality Engineer your responsibilities are to include:
· 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, moulding, assembly, packaging sterilization, warehouse) and attend departmental and other meetings as appropriate;
· Preparation of relevant work sheets and execution of final inspection tests and line clearance verification;
· Release batches in SAP from packaging to sterilization and final release & Complete DHR reviews and batch releases;
· Complete Product Quality Testing & Validating test methods;
· Ensure that maintenance records and process adjustments records are maintained and captured in real time;
· Liaise with relevant personnel regarding flow of product through QC department and other issues that arise;
· Review, analyze and report on relevant customer complaints and institute corrective actions.
The successful candidate will have previous work experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry. The ideal candidate will hold a degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering).
You will have experience of preparing technical documentation and a good knowledge of Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous). You will have experience in CAPA system management and a working knowledge of FDA requirements and managing FDA audits. Good knowledge of SAP and Track wise. You will manage and provide support with ongoing changes and continuous improvement projects e.g. Project Win SPC, automated machine.
This role requires the person to have previous experience of working in process validation and a clean room environment. You will have proven ability of working within a cross functional team and have excellent interpersonal and communication skills coupled with a high level of computer literacy.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287