Our client a leading medical device company Cork is looking to hire a Supplier Quality Engineer for their site on a permanent basis.
The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet requirements. Additionally, the Supplier Quality Engineer will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Help develop and recommend acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.
- Assess suppliers for technical, quality and manufacturing capabilities. Performs assessment of supplier capabilities through desktop assessment, direct on-site visits, and technical discussions and follow-up actions based on results of Supplier Quality System Audits.
- Works under general guidance regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.
- Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
- Communicates quality issues to suppliers as needed and helps develop corrections and corrective actions.
- Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
- Tracks and trends supplier performance, taking remedial action as needed.
- Provides guidance to Purchasing and Engineers in applying Supplier Quality system requirements.
- Reviews, understands, and approve qualification protocol and reports.
- Assist in the processing of supplier change impact assessments through cross functional team.
- Primary relationship owner with supplier providing feedback as warranted to ensure compliance and alignment of supplier specifications.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
- Excellent written and verbal communication skills
- Demonstrated ability to identify and work with cross functional organizations to solve problems
- Strong command of MS Office – Word, Excel, PowerPoint.
- Ability to rapidly learn and use new applications
- Previous experience Supplier Quality, Quality, or Manufacturing background.
- Experience in the medical device industry
- Experience in working with or knowledge of manufacturing technologies associated with Plastics/Metal/Chemical/Extrusion or packaging type components/suppliers
- Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
- Lead auditor certification ISO 13485 or previous auditing experience.
- Experience in problem solving and process improvement methodologies
- Process Validation, Risk Management, CAPA experience.
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