- Reference: GJ43452
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
Reporting to the QA & RA Manager you will provide a support role to the Quality Manager in the routine maintenance of the company’s Quality and other business Management Systems.
- Administration and Organization of the QA Mailbox including recognizing where escalation points are required.
- Compliant distribution – QA approval of Product supporting the interface between commercial organizations/ distribution business and Legal Manufacturers.
- Compliant warehousing and handling – QA approval of Product disposition supporting the interface between Warehouse Inventory Control and Legal Manufacturers
- Continuous improvement – Administration and support of the CAPA/ NC process through weekly continuous improvement meetings.
- Escalation point for quality related non-conformances and CAPAs.
- Execution of product recalls supporting the interface between commercial organisations and Legal Manufacturers.
- Cross-functional Team member – represents QA in cross-functional teams where business needs require.
- Support QA structure for AIL Galway activities.
Skills, Experience and Qualifications:
- Minimum 5 years’ experience in medical device industry, including;
- Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Competency in conducting technical review of all documentation/ communications.
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
For a confidential discussion and more information on the role/company please contact me Amy O’Neill on 091-706718 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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