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.
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