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Design Assurance Engineer

Job Title: Design Assurance Engineer
Contract Type: Permanent
Location: Galway
Industry:
REF: 91045
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

Design Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site.
This position provides QA Technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs.
Key Responsibilities
  • Responsible for compliance of product development, risk management and post market activities with Policies and Procedures and applicable International Regulations.
  • Work as part of product development team in identifying and translating user requirements into design requirements, identifying critical design features and components.
  • Complete design verification, design validation and test method validation activities associated with product development and implementing design/process changes.
  • Work with R&D and manufacturing engineering in translating design requirements into manufacturing requirements, including the development of manufacturing test methods and implementing production monitoring and controls.
  • Resolve project issues by working with team members, suppliers, and others as appropriate. Apply thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
  • Monitor compliance with policies, procedures and applicable regulatory requirements, identifying and implementing process and system improvements.
  • Leads and/or facilitates compliance and improvement activities associated with the quality system (e.g. CAPA).
  • Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, and post market activities.
Essential Skills / Experience:
  • Minimum Bachelor's Degree in Engineering, Science or related technical field, and a 3 years minimum QA, Quality System or regulatory experience in the medical industry a prerequisite.
  • The successful candidate will need a strong technical aptitude with an excellent understanding of their subject matter.
  • Be highly motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.
Key Relationships/ Interfaces:
  • Regulatory, R&D, Clinical, Marketing, Operations, Distribution, External Services Suppliers
Behaviours/ Values
  • Required include strong work ethic, combined with creativity, initiative and great technical capability.
  • Excellent presentation and verbal communication skills are essential.
For further information on this Design Assurance Engineer role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie
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