Job Description
HERO Recruitment are delighted to share we are working in partnership with an innovative and global leader in Medical Technology to attract a Senior Supplier Quality Engineer. This is a permanent position reporting to the Supplier QA Manager, in a hybrid working model. As the organisation records strong year-on-year growth and a new product going to market in the coming years, this is a key hire in a growing team. The Senior Supplier Quality Engineer is responsible for leading quality engineering activities within supplier controls and project teams in addition to the monitoring, approval, and qualification of existing and new suppliers whilst managing all process validations. Key Responsibilities: Ensuring that suppliers deliver quality parts, materials, and services. Build strong relationships with suppliers focusing on strong collaboration, communications, and monitoring/planning activities. Appropriately train, develop, and manage resources within the Supplier Quality Team to ensure objectives are communicated and delivered within agreed requirements. Supporting Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements. Manage and lead all process validation activities including IQ, OQ, and PQ with existing and new suppliers. Ensure effective and timely closure of Quality System documentation (Audit Actions, SCARs, SCNs, PANs, etc.). Lead Quality Engineering support on project activities i.e., Design Improvements, Supplier Transfers, Cost Improvements, and New Product Introductions. Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts. Champion continuous process improvement and, in conjunction with other functions, analyze feedback and identify and implement appropriate problem-solving and statistical techniques to improve the quality of manufactured products and overall effectiveness and efficiency of processes. Overall responsibility for GMP standards and compliance within Project Teams and Supplier Engagement. Key Requirements: At least 6 years of Quality Engineering experience or related role within the medical device/pharmaceutical industry. Understanding of ISO 13485 and FDA QSR standards. Experience with reviewing and approving process validation activities (IQ, OQ, PQ, TMV, etc.). People management experience, proven record in leading for success. The first round of this process will be an in-person interview. As a Senior position, the Hiring Manager is keen for both parties to get a clear sense of each other and the requirements for the role. For further information on this role, please contact Lisa Lawlor on 0868395533 or email stem@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. #J-18808-Ljbffr