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Senior Design Quality Engineer

Senior Design Quality Engineer

Job Title: Senior Design Quality Engineer
Contract Type: Permanent
Location: Dublin
Industry:
Salary: Depending on Experience
Start Date: ASAP
Duration: Permanent
REF: 10761
Contact Name: Heather McGowan
Contact Email: sligo@icegroup.ie

Job Description

We have an immediate need for a Senior Design Quality Engineer who will be the subject matter expert for design controls and quality engineering for a successful global diagnostics manufacturer. This organization is on the cutting edge of technology as it relates to diagnosing diseases (imaging, laboratory, molecular medicine) and digital health/enterprise offerings.

Key elements to this position:

  • Be a Subject Matter Expert; providing expertise across design control for new product development (commercial diagnostics hardware & software); leading QMS (Quality Management System) improvement projects and training efforts
  • Lead effective tools, development, transfer, and maintenance of complex systems throughout the entire product lifecycle
  • Utilize Lean & Six Sigma methodologies across the business
  • Drive quality engineering principals & problem-solving skills/methodologies, risk analysis, statistical techniques
  • Ensure regulatory requirements are adhered to; guiding/recommending new plans if needed (CFR 21 Part 820, EU IVDD, IVDR, ISO 13485, etc.) Be a SME during regulatory inspections.
  • Lead risk management, design verification, process/design validation activities for products and processes
  • Provide supplier quality audit support; implementing design control elements as needed
  • Partner with cross functional teams to ensure test methods are appropriate
  • Lead investigations into quality issues and CAPAs

Qualifications:

  • Bachelor’s Degree required (Engineering, Biotech, Life Science, or Similar)
  • Min 5+ years experience in NPD design quality & control with IVD, laboratory diagnostics, or similar products of regulated nature. Will be a subject matter expert so needs to be able to speak to driving design control success across hardware/software systems working in a matrixed environment with cross functional teams
  • Experience leading Quality Management System improvement projects and training efforts
  • Ability to work independently and in project teams.
  • Excellent communication skills (written and spoken)