Senior Quality Manager

Location: Galway, Ireland Department: Quality Assurance & Quality Engineering

Make a Global Impact in Medical Device Quality

Are you an experienced quality leader looking to take your career to the next level in a dynamic and high-impact environment? We are seeking a Senior Quality Manager to lead and shape the Quality Assurance and Quality Engineering functions at our Galway site. This is a key leadership role within a global organisation committed to excellence in medical device manufacturing and compliance.

Reporting directly to the Global Head of Quality Operations, you will play a critical role in driving quality strategy, maintaining compliance across international regulatory standards, and leading a team of dedicated quality professionals.

What You'll Be Responsible For:

• Leading and developing the Quality Assurance, Quality Engineering, Validation, Calibration, and Microbiology teams on-site.

• Ensuring compliance with global regulatory requirements including 21 CFR 820, ISO 13485, MDR, RDC ANVISA 16/2013, MHLW MO 169, and TG(MD)R Schedule 3.

• Overseeing Material Review Boards (MRBs) to ensure timely and compliant product disposition and initiation of corrective/preventive actions.

• Developing robust systems to support design and production teams in areas such as:

o Quality planning and inspection methods

o Statistical analysis and sampling

o Sterilisation and biological testing

o Application of regulatory standards

• Managing quality controls across the full product lifecycle — from raw material intake to final product release.

• Leading regulatory and customer audits and ensuring audit readiness at all times.

• Driving improvements through structured problem-solving, failure analysis, and CAPA programs.

• Partnering with suppliers to maintain and elevate incoming material and component quality.

• Mentoring and training team members in quality engineering principles, including probability and statistics.

• Tracking departmental metrics, setting clear objectives, and supporting continuous improvement.

What We are Looking For:

• A degree in Engineering or a scientific discipline.

• At least 10 years of experience in a regulated medical device environment, with senior leadership exposure.

• ASQ Certified Quality Engineer (CQE) and/or Six Sigma Green/Black Belt certification preferred.

• Strong working knowledge of international medical device regulations.

• Proven leadership and team development capabilities.

• Excellent analytical, communication, and project management skills.

• High proficiency in quality tools, statistical methods, and problem-solving techniques.

Key Competencies:

• Leadership & Team Management

• Regulatory Knowledge & Compliance

• Risk-Based Thinking

• Data Analysis & Statistical Applications

• Strategic Planning & Execution

• Continuous Improvement Mindset

Why Join Us?

This is a rare opportunity to take ownership of a site-wide quality function at a senior level. You will be empowered to lead change, shape quality culture, and work in a collaborative environment where innovation, compliance, and patient safety are top priorities.

For further information on this Senior Quality Manager role in Galway please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.

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