What you need to know
I’m looking for experienced candidates from the Medical Device industry who are looking for a new challenge in their Quality career. My Athlone based client is looking to bring in a Bought in finished Goods Senior Quality Engineer who will manage and drive all aspects of quality within the business, whilst acting as a consultant and advisor to their contract manufacturing partners.
This is a senior role and although we do not require candidates who have direct reports in previous roles, we are looking for a minimum of 4 – 5 years’ experience in a Quality related role in the Medical Device industry, ideally as a Quality Engineer who is capable of leading major issues when required and to serve as the QA focal point for the Bought in Finished Goods relationship.
This is a permanent job and comes with a competitive benefits package.
Your new job
The successful candidate will have the ability to prioritise tasks and manage several projects simultaneously, ensuring an effective communication and interaction with management at all times through quality presentations, status reports and measurement processes. You will actively contribute to the enhancement of quality and compliance initiatives for all areas of responsibility and work closely with all stakeholders to ensure alignment, resolve problems and share best practices.
Key duties & responsibilities:
- Conduct device evaluations related to product issues and performance
- Identify and effectively issue SCARs where quality issues are identified in relation to product received from suppliers
- Ensures major non-conformance’s and trends are escalated to management and provide support the completion of risk assessment and validations
- Manage Change Controls for the review and approval of supplier and in-house change requests
- Monitor and control progress of supplier quality projects, ensure sound application of engineering, provide project reviews where necessary.
- Actively contribute to the enhancement of compliance initiatives and implement continuous improvement processes with BIFG Suppliers in relation to product quality
- Ensure strict adherence to the requirements of cGMP, including training and documentation
What are we looking for?
- Minimum of level 8 Degree in Engineering, Science or related subject is essential
- Minimum of 4 – 5 years experience working in a Medical Device environment
- Excellent analytical ability and able to work under pressure to achieve deadlines
- Proven leadership skills and SME level of knowledge regarding Quality Systems & Regulatory
- Working knowledge of Oracle/SAP/ERP systems and Business Objects software program
- Good working knowledge of Statistical techniques and methods
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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