Design Assurance Engineer with excellent understanding of ISO 13485 and FDA QS regulations required by growing medical devices client in Sligo.

Requirements:

  • Minimum Degree in a Science or Engineering discipline
  • 3-5 years’ experience working in a medical device environment in a Design Assurance Engineering role (preferably with involvement in Product Design and R&D)
  • Strong knowledge of ISO 13485, FDA regulations 21CFR 820
  • Strong knowledge of MDR & FDA product submission requirement
  • Strong understanding of the general principles of ISO 14971
  • Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required
  • Demonstrate detailed working knowledge of the medical device industry
  • Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers
  • Desire to learn new tasks and flexibility
  • Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives
  • Capacity to maintain the highest level of confidentiality internally and externally
  • Excellent MS Office experience (Word, Excel, PowerPoint etc.)
  • High level of teamwork and engagement

Desirable:

  • Internal/external auditing experience 
  • Validation experience including Sterilization, process and packaging validations 
  • Knowledge of Medical Device manufacturing environment including cGMP 

Responsibilities:

  • Provide technical quality support for Design Assurance guidance & direction to Project Manager, Design Engineer & clients for the duration of a project development
  • Work closely with Product Development Engineering team and the client to establish compliant design and product specification
  • Quality review of design verification protocols & reports
  • Quality review of process validation plan, protocols, and reports
  • Generate & maintain compliant design history files
  • Co-ordinate and contribute to the generation and maintenance of compliant product risk management files
  • Co-ordinate product design reviews and compilation of associated documentation
  • Issue, review, and release of lot records to manufacturing
  • Co-ordinate and review of testing and release on sterilise product
  • Quality review of SOP’s, Work instruction’s, template’s, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures
  • Review and approve product change controls
  • Liaise with suppliers and clients on quality related issues
  • Perform an active role in further development and continuous improvement of the QMS
  • Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints
  • Perform CAPA reports
  • Support clients in product submission to applicable regulatory authorities.
  • Support Quality Department in implementing and maintaining QMS
  • Conduct internal audits and compilation of associated documentation
  • Support and assist in the preparation for customer and surveillance audits

emer@emtechrecruitment.ie 

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