Senior Quality Manager

April 6, 2025
Reference key: ES13659
Permanent
Deadline date:

Job Description

  • Negotiable
  • Permanent
  • Galway city

Senior Quality Manager required by leading MedTech company in Galway to play a pivotal role in managing and optimizing the Quality Management System (QMS) and Quality Manufacturing Engineering across three sites in Ireland. Reporting to the Senior Director of QA/RA, this leadership role will drive continuous improvement, optimize manufacturing processes and ensure full regulatory compliance. You will mentor and lead a high-performance team while ensuring alignment with company goals and culture.

REQUIREMENTS:

  • Bachelor’s Degree in Engineering, Manufacturing, Production Management or Quality Management (Master’s Degree preferred).

  • 10-12 years of experience in quality management and manufacturing quality engineering within the Medical Device or Pharmaceutical industry.

  • 4-5 years of experience managing teams at a senior level across multiple disciplines.

  • Strong technical leadership with experience in automated and lean manufacturing environments.

  • Expertise in ISO 13485, FDA QSR, EU Medical Device Regulation and MDSAP.

  • Experience with eQMS and MES systems.

  • Professional certifications in Lead Auditor, Six Sigma, Lean Management, or Manufacturing Digitization are advantageous.

  • Strategic thinking with a focus on process optimization and continuous improvement.

  • Strong leadership abilities to inspire and guide a high-performance team.

  • Technical expertise in product development, process engineering, and scale-up.

  • Excellent problem-solving and data-driven decision-making skills.

  • Project management experience, ensuring timely and cost-effective delivery of key initiatives.

  • Ability to adapt and thrive in a dynamic, fast-paced environment.

RESPONSIBILITIES:

  • Lead Quality Oversight of processes, applying statistical controls to enhance manufacturing efficiency and consistency.

  • Provide strategic direction on Risk Management (Process FMECA) and ensure robust mitigation.

  • Conduct Root Cause Analysis and manage the NC/CAPA process for sustainable resolution.

  • Oversee Materials Review Board (MRB) compliance and implement inspection plans to meet or exceed product specifications.

  • Champion adoption of cutting-edge technologies, automation and digitalization to optimize manufacturing performance.

  • Contribute to long-term strategic planning, process reengineering and sustainability initiatives.

  • Drive continuous improvement to optimize performance, reduce waste and lower costs.

  • Lead digitization efforts.

  • Oversee quality engineering and QMS programs, ensuring alignment with business objectives.

  • Ensure regulatory compliance (ISO 13485, FDA QSR, MDSAP) and lead internal audits.

  • Lead a high-performing team of 20+ engineers and specialists, ensuring effective recruitment and talent retention.

  • Foster collaboration across sites and guide career development.