Quality Systems Engineer

Job description


Primary Function: Conduct quality-related activities to deliver consistent, high quality documents, services, products and processes, which adds value to the business.

Major Responsibilities: 

  • Contributes to the timely achievement of Quality function's project goals. Provides compliant solutions to a variety of problems of moderate scope and complexity
  • Interacts constructively with employees, managers and cross-functional peers. May lead a project with a limited scope, but usually a contributor on broader projects
  • Provides guidance to other Professionals and Technicians. Leading/supporting customer and regularity audits

 Quality System Compliance: 

  • Maintains awareness of standards that regulate our industry
  • Ensures compliance to site level policies and procedures by promptly reporting and processing non-compliant issues within the business as appropriate
  • Maintains vigilance to ensure adherence to Quality Policy and Quality system

Risk Management Programme: 

  • Applies a high degree of Risk Management principles, methods and tools to work
  • Coordinates quality decisions between different quality and engineering groups
  • Participates in the development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs)
  • Team member helping and interfacing with suppliers to deliver product meeting our quality requirements

Validation Management Programme: 

  • Applies a high degree of Validation Management principles, methods and tools to work. Co-ordinate and maintenance of the Validation programme
  • Key member of projects involving IQ, OQ, and PQ activity (Quality verification and advisory role)

Problem Solving: 

  • Proven ability to successfully use structured problem-solving methods for process improvement and data driven decisions
  • Recommends/implements possible solutions

Soft Skills: 

  • Has proven ability to be a key influencer and leader within projects and cross functional teams
  • Always speaks up to offer opinion to make things better
  • Displays good judgement and communicates well with peers and senior management

 Complaint Evaluation: 

  • Investigates complex complaints with management oversight. Provides compliant solutions to a variety of complex problems

 Design Control/Documentation & Change Control:

  • Identifies areas for process improvement
  • Provides supporting information for change including reasons and justifications.

 Education, Skills and Experience:

  • QQI LEVEL 7 in Quality, Life Science, Engineering, or closely related discipline is required
  • At least 3 years work experience in Quality or related field experience
  • Demonstrates understanding of how their function supports the business
  • Demonstrates technical and business competencies that drive results and continuous improvement
  • Internal auditor experience
  • Working knowledge of ISO17025, ISO9001 & ISO13485 a distinct advantage
  • Proven ability to train staff on complex and technical subject matter


  • Negotiable


To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent