Our client an Indigenous Irish Medical Device company currently seeks a Senior Supplier Quality Engineer. 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 and improvement initiatives. Other activities may be assigned as needed.
• Appropriately train, develop and manage resources within 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.
• Demonstrate strong leadership and a clear identifiable work ethos within the Supplier Quality Engineering Team.
• Work with the Supplier Quality Group to lead engagement with critical Suppliers with regards to EU MDR compliance.
• Manage and led 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, SCAR’s, SCN’s, PAN’s, etc.).
• Lead Quality Engineering support at on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
• Lead Supplier Approval and Supplier Management Activities and manage Supplier Quality assurance process for allocated Suppliers to ensure Supplier Approval Requirements are met.
• 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, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.
• Overall responsibility for GMP standards and compliance within Project Teams and Supplier Engagement.
• Maintain compliance with ISO and FDA Quality System regulations.
• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary.
• The role will require a high degree of flexibility to coordinate the variety of tasks.
• BE/BS Degree.
• A Post-graduate qualification in Quality Assurance is preferable although not mandatory.
• At least 5+ years Quality Engineering experience or related role within the medical device industry.
• Ability to work on own initiative.
• Strong team member with the ability to identify and drive implementation of innovative quality improvements.
• Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.
• Demonstrate and actively promote high levels of professional quality engineering.
• Good communication skills. Must have the ability to communicate effectively at all levels of the company and with suppliers.
• Process Validation and Injection Moulding Experience knowledge.
• Good administrative/organizational ability with high level of attention to detail.
• Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.
• Thorough understanding of ISO 13485 and FDA QSR standards.
For further information please contact James Cassidy email@example.com or call in confidence 086 0204322