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

emer@emtechrecruitment.ie

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