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Senior Design Quality Engineer

Job description

Responsibilities

  • Act as SME for Compliance, Excellence and Regulatory requirements in NPI projects and Quality, specifically with regarding to FDA Quality System Regulations and EU MDR requirements.
  • Support QA and design teams in NPI and New Technology Introduction projects and product design reviews.
  • Work closely with R&D and Process engineers on product risk management files amd post launch risk assessment reviews.
  • Conduct root cause analysis and corrective actions, ensuring quality standards and specifications meet regulatory requirements.
  • Conduct audits internally and externally, ensuring both internal manufacturing and external suppliers have quality standards aligned.
  • Provide rapid resolution support for product complaint or regulatory issues.
  • Work cross functionally with R&D, operations and customers in NPD, NPI and product optimization activities.
  • Provide statistical analysis of verification and validation testing.
  • Review and provide complete adherence for design history files and technical files, supporting the regulatory department in reviewing technical submissions.

 

Requirements

  • A level 8 engineering degree in quality assurance or similar with 5 years or more in a medical device environment
  • Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
  • Working knowledge of 21 CFR 820, ISO13485, MDD and MDR.
  • Preferable candidate will have ISO13485, ISO14971 and QMS regulation experience.

 

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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