A Major Medical Devices Company in Galway, Ireland is seeking to recruit a suitably qualified person for the following post:
SUPPLIER QUALITY ENGINEER
The role will be based in Ireland and reports directly to the Sr Quality Systems Supervisor. The Supplier Quality Engineer is responsible for managing CM & OEM suppliers of finished goods
In this role you will be responsible for Business Development. You will represent CM quality on new product and new supplier qualification projects.
You will be required to perform and monitor qualification and routine audits, negotiate quality agreements, Manage Hold & Recall activities, Customer complaint handling and investigation and the issuing and monitoring of supplier corrective action requests (SCAR).
You will generate, provide and review data for the monthly performance scorecard, provide quality inputs on supplier change request projects and provide training to CM & OEMs on quality system updates and improvements.
You will support supplier remediation activities, quality system and quality culture improvements, the continuous improvement of the external manufacturing quality system and the implementation of quality agreements, specifications, documentation for legacy suppliers and products.
You will liaise with the CM quality team and stakeholders on CM & OEM development the performance monitoring and corrective and preventative actions (CAPA), change control and maintaining an up to date approved suppliers list.
You will participate in project teams associated with product, process or sourcing activities and improvements for outside vended products.
You will liaise between the Company and outsourced manufacturing sites for the deployment and communication of needs and new or improved quality requirements.
You will be responsible for supplier quality activities associated to sub-tier suppliers in the event of acquisitions and divestitures of outside vended suppliers and evaluating purchased product performance as necessary and recommends and implements applicable improvements.
You will occasionally support other BU's, departments, suppliers and customers to address and resolve issues with purchased product.
You will ensure statistical process tools are used effectively to reduce waste and product variability.
You will work with internal auditors on audits or inspections required to be completed on purchased product.
We are looking for a qualified person with a Bachelor's Degree level 8 in a scientific, engineering or technical field.
A minimum (3-5) years' experience in a Medical Device, Quality Engineering or Reliability Engineering function with a demonstrated track record of effectively influencing and negotiating with suppliers and leading effective/successful change initiatives and demonstrated knowledge and experience in: supply chain management and supplier development, risk/issue management, implementation planning, training/communication, scope management.
Candidates must be Fluent in English. Flexibility in travel is mandatory.
Candidates must have in depth knowledge of quality system requirements applicable to medical devices (primarily 21 CFR 820 and ISO 13485) and knowledge of regulatory requirements applicable to medical devices (primarily the MDD, excellent communication skills, both oral and written, strong negotiation skills and a strong working knowledge of Microsoft office packages.
Experience in change control, project management and a working knowledge of inspection and test techniques, quality assurance procedures, statistical analysis, product usage and device regulations are an advantage. ISO 13485 Certified Lead Auditor and 6 Sigma and/or Lean experience (trained or certified) are preferred.
A very attractive Salary/Benefits Package is on offer and negotiable
Please forward your CV immediately to:
For informal enquiries, please ring Christy O'Hara on 087-9473404 or 00353 87 9473404 if outside Ireland