Job Description
Senior Supplier Quality Engineer required by growing MedTech company in Galway to lead quality engineering efforts within supplier management and project teams, oversee the monitoring, approval and qualification of both new and existing suppliers, while also managing all aspects of process validations.Responsibilities:Train, develop and manage the Supplier Quality Team to ensure that objectives are clearly communicated and met within the agreed requirements.Collaborate with the Supplier Quality Group to lead engagements with critical suppliers, focusing on EU MDR compliance.Manage and lead all process validation activities, including IQ, OQ and PQ, for both existing and new suppliers.Build strong relationships with suppliers, including third-party logistics providers and distributors, emphasizing collaboration, communication and planning activities.Lead Quality Engineering support for project activities, including design improvements, supplier transfers, cost reductions and new product introductions.Oversee Supplier Approval and Management activities, ensuring that Supplier Approval Requirements are met.Take overall responsibility for maintaining GMP standards and compliance within Project Teams and Supplier Engagements.Ensure adherence to ISO and FDA Quality System regulations while managing and leading all process validation activities with both existing and new suppliers.Requirements:Bachelor's Degree in Engineering or a related field is required.At least 8 years of experience in Quality Engineering or a related role within the medical device industry is required.Capable of working independently with strong initiative.A collaborative team player who can identify and drive the implementation of innovative quality improvements.Proven ability to work within project teams, consistently meet deadlines and ensure all actions are appropriately addressed.Exhibits and promotes high standards of professional quality engineering.Strong communication skills, with the ability to effectively communicate at all levels within the company and with suppliers.Knowledge of Process Validation and Injection Molding.Strong administrative and organizational skills with a high level of attention to detail.Proficient in liaising with suppliers, customers, and regulatory contacts in a professional and informed manner.In-depth knowledge of ISO 13485 and FDA QSR standards.IDEAL:A postgraduate qualification in Quality Assurance is preferred but not mandatory. #J-18808-Ljbffr