1.1 The Quality Engineer will provide on-going support to the operations team to maximize product quality performance to the customer and quality systems compliance to all required regulatory standards.
1.2 The Quality Engineer will be responsible for the implementation of procedures and processes, with a focus on implementing best practice in the Automation Room and ensuring the quality system requirements are suitably implemented and in compliance with all relevant standards, policies and procedures, to the satisfaction of all stakeholders internal and external.
1.3 Principle Duties and Responsibilities
- To strictly comply to all approved procedures within the Quality Management System, at all times
- Where identified to raise opportunities for improvement, which can be reviewed and if appropriate implemented within the Quality Management System
- Investigate the root cause of any customer complaints that are assigned and address these in a timely manner using problem solving methods. (8-D Corrective Action! Fishbone, etc.).
- Create IPC programmes for products that are manufactured and generate SPC data for each production run.
- Trend SPC analysis on a quarterly basis as per customer request and report any changes in the SPC trend of relevant products to the Quality Manager.
- Monitoring and Control of Calibration within the Automation Room.
- Handle all product and material trial documentation. Complete any dimensional studies that may be required in relation to trials or as specified by the customer.
- Ensure any machine or process changes go through rigorous change control procedures.
- Implement GAMP – Good Automated Manufacturing Practices and GDP – Good Distribution Practices in the Automation Room.
- Reports Validation and CAPA performance to Senior Management monthly or as required.
- Support the Auditing programme both internal and external in relation to auditing activities, corrective actions and audit close out.
- Carry out staff training as required such as procedural changes to documentation such as work instructions, QAP’s, QSS’s etc.
- Actively participate in Lean initiatives & proactively help improvement teams
- Plan, Co-ordinate and support the execution of validation and IPC activities.
A degree in a relevant Quality / Engineering / Technology / Science discipline orequivalent third level Quality Qualification required.
- Experience in Regulatory standard ISO 13485 and validation.
- Experience in cGMP and GAMP.
- A minimum of 3 years’ experience in a quality role in a pharma, medtech or an injection moulding company required.