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Design Assurance Engineer

Job Title: Design Assurance Engineer
Contract Type: Permanent
Location: Sligo
Industry:
REF: 11086
Contact Name: Heather
Contact Email: sligo@icegroup.ie

Job Description

Our Client is seeking to hire a Design Assurance Engineer to provide technical support to Design Engineers, Project Managers and Clients throughout product development processes.

The ideal candidate will be coming from a background in Medical Devices and have a minimum of 3 years of experience working in Product Design and R&D. This role reports to the Engineering Manager. It is a Full time, Permanent position.

Personal Profile

  • 3rd Level Qualification in Engineering or Science discipline
  • Minimum 3 years in Medical device Environment and knowledge of cGMP.
  • Experience in Validation (Process, Packaging, sterilization) would be a distinct advantage.
  • Excellent communication skills, written and verbal, and the ability to communicate with the team, managers and clients in a clear and appropriate manner.
  • Strong numerical and problem-solving ability.
  • Knowledge of MDR & FDA Product submission requirements.
  • Strong knowledge of ISO 13485, FDA Regulations 21CFR820

Duties and Responsibilities

  • Working closely with clients and the product development engineering team to complete designs and products that are compliant with FDA regulations
  • Performing quality reviews of process validation plans, design verification protocols and reports.
  • Constant reviewing of production SOPs, work instructions and material specifications to ensure compliance with cGMP procedures.
  • Keep accurate and up to date files at all stages of product development
  • Coordinate product design reviews and complete associated documentation.
  • Support Quality Department in implementing and maintaining QMS
  • Provide support for audit preparation
  • Other duties as required by management
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