Our client, a medical device company in Galway are currently looking to recruit a Quality Technician for their site.
Completion of investigations of reported complaint events and associated product evidence returned to our client and provision of excellent service to customers both internal and external customer of patients and user of the product.
- Completes analysis on returned product samples using available methods/equipment and applying problem solving and investigation skills.
- Summarises investigation detail into complaint records within the Global Complaints System Management system (GCMS). Generate and update QA Documentation as directed.
- Maintenance of laboratory equipment to our clients requirements and ensure compliance to procedures
- Usage of the laboratory area in accordance with GLP/GMP procedures. Completion of assign area audits and as applicable support internal audits.
- Completion of decontamination of return product, as required
- Participates in continuous improvement projects to the investigation methodology and associated processes.
- Support Quality Engineering team as required and share output of investigation work as appropriate
- Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
- Work collaboratively within the Galway CIS team and with other CIS centres and Complaint Management centres (CMCs) across the Post Market Quality Assurance function
- Development and maintenance partnerships with Quality Operations, Design Assurance and R&D for the execution of insightful investigations and to support product performance improvements.
- Knowledge: Solid knowledge of the job. Applies broad knowledge of business concepts, procedures and practices and a general understanding of department fundamentals.
- Cognitive Skills: Performs routine and some non-routine assignments using standard methods and sequences. Makes adjustments, modifications, and replacements to set processes as directed. Assignments require limited judgment in troubleshooting proven processes.
- Supervision Received: Close to moderate supervision. Receives general instructions on routine work and detailed instructions on new assignments.
- Consequence of Errors: Errors may be detected and corrected but may cause moderate loss of time or customer/user dissatisfaction.
- Contacts: Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.
- HETAC Level 7 or above in Science or Engineering Discipline. Minimum of 2-3 years in a similar role.
- Knowledge of product design, manufacture, functionality and/or clinical use environment an advantage.
- Hepatitis B Vaccinations course required to work with returned decontaminated product.
- Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
- Good interpersonal skills and organizational skills with excellent attention to detail
For further information on this in please contact Clara Burke on firstname.lastname@example.org
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