Senior Quality Engineer

Morgan McKinley

  • Dublin
  • Contract
  • Full-time
  • 1 month ago
Duration: 12 Months (with possibility of extension)Are you a proactive Quality Engineer with a passion for ensuring top-tier compliance? We're seeking a meticulous professional to maintain the QMS and drive validation excellence.The OpportunityYou will be instrumental in keeping our QMS "Audit Ready," owning CAPAs, and leading internal quality training. This role offers a dynamic blend of QMS oversight, hands-on validation, and critical documentation responsibilities within a regulated environment.Key Responsibilities
  • QMS & Compliance: Maintain an "Audit Ready" QMS, own CAPAs, and conduct internal quality training.
  • Data Integrity & Change Control: Drive data integrity and manage change control processes.
  • Validation & Commissioning: Create and execute FAT, commissioning, and SAT protocols. Develop, coordinate, and review validation documentation (DQ, IQ, OQ, PQ, MVP).
  • Documentation: Perform URS gap analysis, maintain RTMs, and prepare document packs for design gates and package turnover.
  • Problem Solving: Proactively anticipate and resolve issues during validation activities.
  • Collaboration: Work closely with Operations, Validation, and other teams, ensuring audit-ready documentation.
What You'll Bring
  • Education: Bachelor's Degree in Mechanical, Mechatronic/Electromechanical, or equivalent.
  • Experience: 2-5 years
  • Knowledge: Strong understanding of ISO 13485, ISO9001, FDA 21 CFR Part, and GAMP5.
  • Skills: Medical device technical writing and validation/qualification experience for processes, systems, and equipment. Experience in Computerized System Validation (CSV) is an advantage.
  • Attributes: Ability to work independently, self-sufficient, proactive, and a strong team player.

Morgan McKinley