Quality Engineer with medical devices experience required by growing medical devices company in Galway. Joining a multi-site team serving global markets, you will be responsible for quality engineering activities for manufacturing processes, materials, and products as well as within Project Teams. 

Requirements: 

  • Bachelor’s Degree in a relevant Engineering or Science field
  • 1-3 years’ Quality Engineering experience
  • Good understanding of ISO 13485:2003, 2012 and FDA QSR
  • Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
  • Ability to work on own initiative
  • Strong team member with the ability to identify and drive implementation of innovative quality improvements
  • Ability to consistently meet deadlines
  • Demonstrate and actively promote high levels of professional quality engineering
  • Good communication skills
  • Ability to write clear, concise technical protocols and reports
  • Good administrative/organizational ability with high level of attention to detail

Key Responsibilities:

  • Quality Engineering support of manufacturing process including Investigation of root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s in addition to addressing ongoing compliance

  • Works with team of Quality Inspectors to ensure all work priorities are properly planned, assigned and adjusted if needed to meet daily, weekly, monthly customer sales order requirements

  • Supports Quality reporting metrics; provides data for tracking metrics. Assists in development of root-cause analysis and ensures corrective/ preventive actions are implemented to address non-conformances

  • Initiation and support of continual improvement solutions for new and enhanced methods for inspection, testing, and evaluation of data throughout processes

  • Work with relevant Engineering Teams to establish inspection plans, frequencies and test methods for incoming material/parts

  • Overall responsibility for GMP standards and compliance within the manufacturing area

  • Manage assigned aspects of the quality system in compliance with ISO 13485, FDA QSR, MHLW and Canadian Quality System requirements

  • Support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary

  emer@emtechrecruitment.ie

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