Senior Quality Engineer
Galway

Permanent
Senior Quality Engineer

Role Overview
  • Provide support for Corrective and Preventive Actions (CAPA).
  • Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
  • Supports business initiatives for process improvement.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
  • May provide guidance, coaching and training to other employees within job area, and may manage projects requiring delegation of work and review of others’ work product.
  • Interface with other departments to ensure that Quality system requirements are adhered to.
  • Perform audits and provide audit support
  • Approval of protocols, reports, and testing results
  • All other duties as assigned.

Key Skills & Experience
  • Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science)
  • 5-8 years’ experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
  • Excellent working knowledge of Quality System Requirements within the Medical Device/Healthcare industry
  • Knowledge of FDA and ISO compliance
  • Must be capable of carrying out documentation related responsibilities as well as technical responsibilities
  • Ability to work well as part of team and also to lead a team
  • High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.
  • Ability to take initiative, to organize and prioritize own work and proactively contribute to project level strategies and planning.
  • Effective time management skills.
  • Ability to write engineering documents, test protocols, FMEAs
  • Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.
  • Able to analyze and chart data using MS Excel or Minitab
  • Previous Quality Auditor experience is desirable, or certification is an advantage

Nice to Have
  • Knowledge of quality tools:
  • Risk analysis
  • Root cause analysis
  • Problem solving approaches
  • May have practical knowledge of project management.
  • Green Belt or Black Belt in DRM
  • Experience in Pre or Post-Market Medical Device Design and Development
  • Proficient use of statistical analysis software 
  • Experience with matrix structures, having already worked with cross functional teams within an international environment