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Quality Technician - Dublin, Ireland - Cpl
Description
On behalf of our client, we currently have an excellent opportunity for a Quality Technician to join a growing Medical Technology company. Dublin location, predominately site based with some hybrid.
The Quality Technician will work closely with colleagues to support the following activities:
· Creation, review, and approval of QMS documentation.
· Process and product development activities (including validations).
· Execute troubleshooting and investigation activities.
· Assist in analysis of returned product.
· Support operational, facilities and equipment management activities.
· Assist in incoming inspection process.
Responsibilities and Essential Functions:
· Work cross functionally with customer support teams to ensure timely and accurate documentation of customer complaints.
· Assist in investigation of customer complaints and the analysis of returned product.
· Analyse data to identify trends in product quality or defects with the goal of mitigating and preventing recurrence and future defects.
· Identify opportunities to enhance the effectiveness of the quality system and product quality.
· Participate in operational excellence and continuous improvement initiatives using recognised methodologies such as Six Sigma, Lean, Kaizen etc.
· Assist in the maintenance of QMS performance KPIs and preparation of associated reports.
· Assist in the development and maintenance of document control and record management processes.
· Assist in the assignment of QMS training requirements and maintenance of related records.
· Lead spreadsheet validation activities.
· Assist in product related validation and verification activities, as needed.
· Support the execution of the internal audit process and 3rd party audits.
· Any other reasonable duties as required.
Qualifications and Experience:
· Third level Engineering/Manufacturing/Science degree qualification or equivalent.
· 1+ years in regulated work environment (preferably in Medical Devices).
· Internal/Lead Auditor training preferable.
Key Skills
· A self-starter in terms of time and task management and operate with minimal supervision.
· Strong problem-solving ability.
· Good communicator both verbally and in writing with ability to influence.
· Ability to meet deadlines.
· Good understanding of ISO 13485 and FDA QSR quality standards.
· Proficiency in use of desktop software applications such as MS Office.
For full details contact Linda at or email your CV to Thornshaw Scientific is a division of the CPL Group