Our client is a well-known global healthcare leader. The Associate Quality Engineer provides a support role to the Quality Manager and will report to the QA & RA Manager.
This role would be suitable for candidates who have 2/3 years’ experience working as a Quality Technician within a medical device or pharma environment.
Duties and Responsibilities
- Possesses and applies fundamental and increasing knowledge of Quality, and its application within the company, to the completion of routine assignments.
- Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems.
- Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
- 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 and customer notifications 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 company Galway activities.
Education & Experience
- Minimum 2 years’ experience in the 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 a technical review of all documentation/ communications.
- Broad knowledge of engineering and technical applications applied in the development of medical devices useful.
- 3rd level qualification; minimum level 7.
- Health Insurance
- Pension Scheme
- Generous annual leave allowance
- Life Assurance
- Base salary in line with market