Supplier Quality Engineer – Distributor & 3PL – with at least 3 years Quality Engineering/Assurance experience within the medical device industry required by innovative medical devices company in Galway

RESPONSIBILITIES:

• Support the selection, development and management of new suppliers, distributors and 3PL providers to ensure Supplier & Distributor Approval Requirements are met
• Engage with Suppliers, Distributors and 3PL providers on root cause investigation 
• Collaborate with Distributors & 3PL suppliers to establish quality agreements 
• Participate in business reviews with Distributors, 3PL providers and suppliers 
• Build strong relationships with Distributors, 3PL’s and suppliers focusing on strong collaboration, communications and planning activities
• Support the implementation of and maintain compliance to supplier, Distributor and 3PL EU MDR requirements with key interaction with Regulatory Affairs Department
• Manage and drive continuous improvement activities focusing on quality assurance in the areas of supplier, distributor and third-party logistics management
• Maintain compliance with ISO, FDA Quality System regulations and other applicable worldwide regulations pertaining to the business.

Requirements:

• Minimum of a Degree in a Quality/Engineering/Science or related discipline
• At least 3-5 years Quality Engineering/Assurance experience or related role within the medical device industry
• Thorough understanding of ISO 13485, ISO14971, the FDA QSR standards and the Medical Device Directive, EU Medical Device Regulation 2017/745
• Flexibility to travel when required
• Excellent planning and coordination skills
• Effective verbal and written communication skills
• Strong attention to detail
• A dynamic team player can work effectively and proactively on cross-functional teams
• Ability to work on own initiative
• Qualified Lead Auditor, preferably within the Medical Device Industry desirable
• Demonstrate and actively promote high levels of professional quality engineering/quality assurance
• Ability to liaise with suppliers, 3rd parties, customers and regulatory contacts in an informed professional manner