Senior Supplier Quality Engineer - County Tipperary.
This role is being offered as an initial 15 months' fixed-term contract.
Working with cross-functional partners and suppliers to resolve quality issues and playing a key part in leading the performance improvement of suppliers and increasing the supplier’s capabilities to consistently meet company requirements. Support global sourcing, supplier engineering, and global quality systems by participating in value improvement projects and global communities of practice.
Key Responsibilities: • Responsible for quality performance of Sourced Finished Medical Device manufacturers (OEM and Contract Manufacturers) • Provide appropriate issue oversight, risk evaluation, and action to mitigate impact to the company • Responsible for engaging suppliers to proactively reduce risk to patient and revenue streams • Responsible for partnering with Supplier Engineering and Commercial Sourcing to meet category strategic plans and objectives • Partnership with supplier on process improvements for capability, reduction in risk, single point failures, etc. • Communicate effectively with all Internal & External Stakeholders- building strategic and trusting relationships through collaboration and teamwork • Support transition of SFMD's to EU MDR and support Divisional EU-MDR implementation activities • Maintain and update Supplier Agreements, Complaint Management Plans, Finished Good Documents, Parts etc.
Education & Experience requirements: • Bachelor’s Degree in Engineering, Science, Quality Assurance or similar (minimum level 8) • At least 2-5 years' experience of supplier quality including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realisation, Validation and CAPA • Experience in systems such as Windchill, NCEP, SCAR, SCIA would be an advantage as well as lead auditor experience • The ideal candidate will have some experience in production and process controls, problem solving and have excellent communication skills. • Excellent interpersonal and communication skills with good leadership abilities. • Excellent analytical and problem solving skills. • Candidates should have a proven track record of working in a fast-paced environment with strong technical capabilities and be capable of handling multiple development aspects of assigned projects.